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Versanail - Universal Nailing System - Depuy - ST

The Femoral Universal Nailing System by DePuy Orthopaedics is designed for treating various femoral fractures using antegrade or retrograde approaches, featuring a standardized technology platform for ease of use. The system includes a range of implants made from TiMAX titanium alloy, offering superior strength and flexibility. The brochure outlines the surgical technique, including canal preparation, nail insertion, and locking procedures, emphasizing the importance of proper alignment and fluoroscopic verification throughout the process.

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0% found this document useful (0 votes)
31 views32 pages

Versanail - Universal Nailing System - Depuy - ST

The Femoral Universal Nailing System by DePuy Orthopaedics is designed for treating various femoral fractures using antegrade or retrograde approaches, featuring a standardized technology platform for ease of use. The system includes a range of implants made from TiMAX titanium alloy, offering superior strength and flexibility. The brochure outlines the surgical technique, including canal preparation, nail insertion, and locking procedures, emphasizing the importance of proper alignment and fluoroscopic verification throughout the process.

Uploaded by

regulatory
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 32

®

Femoral Universal

S U R G I C A L T E C H N I Q U E

FEMORAL UNIVERSAL
NAILING SYSTEM
OPTIONS MADE EASY
1

TABLE OF CONTENTS
DESIGN SUMMARY 2
IMPLANT OVERVIEW 3
ANTEGRADE ENTRY AND CANAL PREP 4
ANTEGRADE NAIL INSERTION 8
ANTEGRADE LOCKING 10
RETROGRADE ENTRY AND CANAL PREP 14
RETROGRADE NAIL INSERTION 17
RETROGRADE LOCKING 20
END CAP PLACEMENT 23
NAIL REMOVAL 24
ESSENTIAL PRODUCT INFORMATION 26
IMPLANTS 27
INSTRUMENT CATALOG NUMBERS AND DESCRIPTIONS 28

Note: This brochure presents a surgical technique available for use with the DePuy
Orthopaedics, Inc., VersaNail® Platform instruments and implants. Surgeons may need to
make modifications as appropriate in their own surgical technique with these devices
depending on individual patient requirements.
2

DESIGN SUMMARY

MADE EASY
OPTIONS
The DePuy VersaNail Femoral Universal Nail is part of a long bone nailing
system that offers a complete portfolio of implants and instruments based
on a single, standardized technology platform.

DESIGN SUMMARY
The Femoral Universal Nail System from the VersaNail Platform offers
options to treat a range of femoral fractures using either an antegrade or
retrograde approach with one implant. The VersaNail Platform instrumentation
system is designed for intuitive assembly and ease-of-use by OR staff
and surgeons, enabling a simpler and more efficient procedure. The
instrumentation is designed to provide intra-operative options including
entry portals, reduction tools and color-coded screw placement, while
being standardized to maintain commonality across the platform.
3

IMPLANT OVERVIEW
IMPLANT MATERIAL
All implants are manufactured from Ti-6Al-4V grade, type II anodized titanium
alloy (TiMAX™) due to this material’s superior properties. TiMAX offers a lower
modulus of elasticity and increased fatigue strength over stainless steel.

IMPLANT OVERVIEW
The Femoral Universal Nail is designed to treat:
• Femoral shaft fractures
• Proximal or mid-shaft femoral non-unions and malunions
• Pathologic fractures in osteoporotic bone of the diaphyseal area
• Revision procedures

Antegrade Locking Options Fig. 1 The Universal Femoral Nail hole configurations provide
a number of locking possibilities (Fig. 1). The Femoral Universal Nail
is locked with 6.5 mm screws on the drive end and 4.5 mm screws
on the non-drive end. The locking instrumentation is color-coded
for ease of use.

Color Guide Screw Size Drill Bit Size


Black 6.5 mm Cortical 5.3 mm
Gold 6.5 mm Cancellous 6.5 mm/4.8 mm Step Drill
Silver 3.2 mm Guide Pin Sleeve
Retrograde Locking Option Green 4.5 mm Cortical 3.8 mm
4
UNIVERSAL ANTEGRADE SURGICAL TECHNIQUE
ANTEGRADE ENTRY AND CANAL PREP
Fig. 2 Patient Positioning
Place the patient in the supine position on a fracture or radiolucent
imaging table (Fig. 2). Lateral access to the proximal femur is
required. The affected leg must be adducted and the trunk secured
and bent toward the opposite side. The contralateral leg may be
flexed at the hip or scissored below the affected leg.

Entry Site and Surgical Approach


Identify the entry site, which is in the piriformis fossa. The ideal entry point is
adjacent to the greater trochanter at the lateral edge of the piriformis fossa.

Fig. 3 Initiate the entry site with a 3.2 mm guide pin through a
stab incision proximal to the trochanteric region, in line with
the femoral axis. Confirm correct entry location and guide pin
placement radiographically with AP and lateral views (Fig. 3).
The guide pin placement should be in line with the center of
the femoral canal in both views.
5
Fig. 4 Once the ideal entry point has been achieved, an
appropriate incision can be made. Extend the entry incision
1-2 cm (Fig. 4).

Fig. 5 The entry portal sheath (Cat. No. 2810-13-005) and


trocar (Cat. No. 2810-13-004) can be advanced over the
guide pin down to the piriformis fossa. Parallel guide holes
allow for accurate adjustment of pin positioning. Remove the
trocar from the entry portal, keeping the guide pin in place.
The entry portal sheath may be left in place to protect soft
tissues during canal entry and reaming (Fig. 5).
6
Fig. 6 Canal access can be obtained using either a cannulated
entry reamer or cannulated awl (Cat. No. 2810-01-005). Both
12 mm (Cat. No. 2810-13-001) and 13 mm (Cat. No. 2810-
13-002) entry reamers are available depending on surgeon
preference. The proximal nail diameter is 12 mm for all nail
sizes equal to or less than 12 mm, and 13 mm to 15 mm
nails have a proximal diameter equal to the nail diameter.
Use A/P and lateral fluoroscopic views to confirm accurate
placement (Figs. 6 and 7). Use the awl or entry reamer to
open the proximal femur in the piriformis fossa.

Fig. 7

Note: If utilizing the cannulated entry reamer, the length of the distal portion of
the reamer is enlarged and matches the length of the drive end portion of the
nail. Fluoroscopically verify the entry reamer has been inserted to the proper
depth that will correspond with the depth of the nail.

Fig. 8 Once access to the femoral canal has been gained,


place the ball nose guide wire into the entry site utilizing the
pistol-style guide wire gripper (Cat. No. 2810-01-001) (Fig. 8).
If preferred, a T-handle guide wire gripper (Cat. No. 2810-01-
002) is also available as an option.
7
Fig. 9 Fracture Reduction
Once access to the femoral canal has been gained, obtain
appropriate anatomic reduction in order to restore length,
alignment and rotation of the injured limb. Reduction can be
achieved through the surgeon’s preferred method such as
traction and/or an external fixator. To aid in manipulating the
fracture fragments and passing the ball nose guide wire, large
(7.5 mm diameter, Cat. No. 2810-01-007) and small (6.5 mm
diameter, Cat. No. 2810-01-008) reduction tools are available
(Fig. 9).

Insert the reduction tool into the medullary canal, past the
fracture site. Once the fracture is aligned, pass the ball nose
guide wire, available in both 80 cm (Cat. No. 2810-01-080)
and 100 cm (Cat. No. 2810-01-100) lengths, across the
fracture site. Remove the reduction tool.

Fig. 10 Canal Preparation


Achieve proper alignment of the fracture prior to reaming
and maintain it throughout the reaming process to avoid
eccentric reaming. Initiate reaming by placing the VersaNail
Flexible Reamers over the DePuy 3.0 mm ball nose guide
wire (Fig. 10). Ream the medullary canal in millimeter
increments until cortical bone is reached and half-millimeter
increments thereafter. Surgeon preference should dictate
the actual extent of intramedullary reaming. Monitor the
reaming procedure using image intensification to avoid
eccentric or excessive cortical reaming.
8

ANTEGRADE NAIL INSERTION Fig. 11 Nail Size Selection


An X-ray template including 10 percent
magnification is available to determine
nail size preoperatively (Cat. No. 2810-
13-025) (Fig. 11).

Nail Diameter Selection


Generally, a nail diameter 1 mm to 1.5 mm less than the final reamer diameter is
chosen. Femoral Universal Nails are available in 1 mm increments from 9 mm to
15 mm diameters.

Fig. 12 Nail Length Selection


With the tip of the ball nose guide wire at the level of the
desired depth of nail insertion, slide or snap the nail length
gauge (Cat. No. 2810-01-031) onto the ball nose guide wire
until the nose contacts the bone, ensuring the tip does not fall
into the existing entry canal, which could result in an inaccurate
measurement (Fig. 12).

Fig. 13 To obtain the appropriate nail length, read the measurement


mark on the nail length gauge that is closest to the beginning of
the black transition area on the guide wire (Fig.13). If a nail of the
exact measured length is not available, choose a shorter nail
of the next closest available length. A direct measurement can
also be taken of the uninjured extremity using either radiographs
with magnification markers, or directly on the uninjured limb.

Fig. 14 Nail/Jig Assembly


Place the nail on the femoral insertion handle in the correct
orientation. The nail should be oriented on the femoral
insertion handle such that the anterior bow of the nail is in line
with the anterior bow of the femur and the jig is lateral to the
nail. Secure the nail to the femoral insertion handle by
inserting the femoral jig bolt (Cat. No. 2810-13-008) through
the cannulation of the nose and tightening with the jig bolt
driver (Cat. No. 2810-13-006) and T-handle (Cat. No. 2810-
01-004) (Fig. 14).
9
Fig. 15 Nail Insertion
Once proper reduction has been achieved, insert the nail over
the 3 mm ball nose guide wire into the medullary canal
(Fig. 15). It is important not to strike the femoral insertion handle
directly.

Fig. 16 Attach the hammer pad (Cat. No. 2810-13-011) to the


insertion handle (Fig. 16). Ensure that the hammer pad is
tightened thoroughly prior to impaction. Avoid excessive force
when inserting the nail. If the nail jams in the medullary canal,
extract it and choose the next-smaller diameter nail or enlarge
the canal appropriately.

Fig. 17 Note: The femoral insertion handle is marked with


three grooves (Fig. 17). The groove closest to the nail is
an indicator for the nail/insertion handle junction. A K-wire
can be inserted lateral to medial through the target arm if
additional identification of the nail/ insertion handle junction
is needed. The middle groove is marked 5 mm from the top
of the nail and the groove farthest from the nail is marked
15 mm from the top of the nail. Ensure the nail is seated to
proper depth for planned dynamization.
15 mm

5 mm
nail/jig
junction

Confirm fracture reduction and ensure appropriate nail insertion depth proximally and distally with
biplanar fluoroscopy. Remove the ball nose guide wire.
10

ANTEGRADE LOCKING Dynamization


A dynamic slot has been incorporated in the drive end and non-drive end of the nail. The
drive end slot has a 10 mm range of dynamization. The non-drive end slot has a 5 mm
range of dynamization. If dynamization is planned, countersink the nail to the appropriate
depth to avoid backing out of the nail into the proximal soft tissues. Lock the M/L slot in
the dynamic mode. Delayed dynamization may be performed at a later date with the
removal of the static screws.

Fig. 18 Universal Target Arm Assembly


Attach the radiolucent universal target arm (Cat. No. 2810-
13-009) onto the insertion handle, using the target arm
attachment bolt (Cat. No. 2810-13-026) and hand tighten
(Fig. 18). Ensure the target arm is properly secured to the
insertion handle for excellent targeting.

Locking
Prior to locking both proximally and distally, check femoral length and rotational alignment.
The nail can be locked either distally or proximally first, depending on surgeon preference.

Fig. 19 Proximal Locking


The universal target arm is marked to identify which locking
option is being targeted (Fig. 19).

Fig. 20 Place 6.5 mm cortical locking screws using the black


instrumentation (Fig. 20).
11
Fig. 21 Place the 6.5 mm screw sheath (Cat. No. 2810-13-020)
and trocar (Cat. No. 2810-13-021) through the appropriate
holes in the jig’s targeting arm to locate the incision site
(Fig. 21). Make a stab incision and advance the sheath and
trocar to the bone. Soft tissue dissection should be completed
sharp and precise to clear a path for the sheath. Undue soft
tissue tension against the sheath can cause misdirect drilling.

Fig. 22Note: A 3.2 mm x 17.5 in guide pin (Cat. No. 9030-03-004)


and 3.2 mm pin guide sleeve (Cat. No. 2810-13-018) can be
used to verify screw position prior to drilling (Fig. 22).

Fig. 23 Remove the trocar and replace it with the 5.3 mm drill
sleeve (Cat. No. 2810-13-022) (Fig. 23).

Fig. 24 Utilizing the 5.3 mm drill bit (Cat. No. 2810-13-153) drill
through the drill sleeve and sheath until the far cortex is
penetrated (Fig. 24).
12
Fig. 25 Read the calibration on the drill bit that lines up with the
drill sleeve to determine the screw length (Fig. 25).

Fig. 26 If further screw length is required, or if the locking hole


has been initiated with a guide pin, a 6.5 mm screw depth
gauge (Cat. No. 2810-13-035) is available to read screw
length off of the 3.2 mm x 17.5 in guide pin (Fig. 26).

Fig. 27 Verify fluoroscopically to assure the proper screw length


selection. Remove the drill sleeve. Using the 6.5 mm screwdriver
shaft (Cat. No. 2810-13-024), insert the 6.5 mm cortical
screw through the sheath. The etch mark on the screwdriver
corresponds with the screw sheath to indicate when the
screw is fully seated (Fig. 27).

Repeat above steps for additional screw placement.

Fig. 28 Distal Locking


Place 4.5 mm cortical locking screws using the green
instrumentation (Fig. 28).
13
Fig. 29 Use fluoroscopy to conduct freehand locking utilizing a
familiar freehand technique. A black radiolucent wand (Cat.
No. 2810-12-016) is available to aid in freehand locking (Fig. 29).

Fig. 30 Accurate C-arm position is confirmed when the distal


nail hole appears to be a perfect circle. Once correct
placement has been verified fluoroscopically, make a stab
wound in direct alignment with the distal hole (Fig. 30).

Fig. 31 Using the 3.8 mm drill bit (Cat. No. 6 in: 2810-12-138 or
8 in: 2810-13-138), drill until the second cortex is penetrated. Verify
the drill bit position fluoroscopically prior to taking any measure-
ments. Place the green 4.5 mm screw length gauge
(Cat. No. 2810-01-032) onto the calibrated drill bit and advance
down to the bone. Read the calibration on the drill bit that
corresponds to the measurement line indicated on the screw length
gauge (Fig. 31). A screw depth gauge (Cat. No. 2810-01-017) is
also provided for further screw length verification. For an accurate
reading, take care to ensure the 4.5 mm screw length gauge or
screw depth gauge sheath is fully seated on the bone.

Remove the drill bit and advance the 4.5 mm screw. Repeat
above steps for additional screw placement. The SolidLok™
screwdriver (Cat. Nos. 2810-01-020 and 2810-01-021) can be
utilized to capture the screw while passing it through soft tissue
during screw placement.

A compensation factor is built into Fig. 32


the measurement of the screw
Determining Screw Length
depth gauge (for the screw head
and cutting flutes), and the calibrated
The screw size indicates the total measurementfrom the tip to the
drills (for the screw head only). screw head. The calibrated drills and the screw
depth gauges have
Depending on the surgeon a compensation factor built into the measurement such that the
preference for cutting tip
extension, 3-5 mm may be reading should indicate the exact size screw to achieve bi-cortical
added to the reading when using purchase. To ensure a proper reading, the screw depth gauge
the calibrated drill.
and drill sleeves must be touching bone. Fluoroscopy is
recommended to verify the correct screw length (Fig. 32).
14

RETROGRADE ENTRY AND CANAL PREP UNIVERSAL RETROGRADE SURGICAL TECHNIQUE

Fig. 33 Patient Positioning


Place the patient in the supine position on a fracture or
radiolucent imaging table (Fig. 33). Place the knee in
approximately 45 degrees of flexion. Use manual traction,
a femoral distractor or an external fixator to reduce severely
displaced fractures and maintain length. Special attention is
needed to maintain proper length when using a retrograde
approach to treat a comminuted fracture.

Fig. 34 Entry Site and Surgical Approach


Identify the entry site, which is above the intercondylar notch
(Fig. 34).
15
Fig. 35 Approach the distal femur through a midline longitudinal
incision between the patella and the tibial tubercle (Fig. 35).
Obtain access to the intercondylar notch by splitting the
tendon longitudinally or displacing the tendon laterally.

Alternative approach: Approach the distal femur through a longitudinal incision from the
superior pole of the patella to the tibial tubercle, placed along the medial border of the
patellar tendon. Expose the intercondylar notch by using retractors to reflect the patellar
tendon laterally or perform the procedure percutaneously.

Fig. 36 Place the guide pin in the center of the intercondylar


notch approximately 1 cm anterior to the posterior cruciate
ligament and confirm accurate guide pin placement in two
planes fluoroscopically prior to reaming. The guide pin
placement should be in line with the center of the femoral
canal in both views (Fig. 36).
16
Fig. 37 Canal access can be obtained using either a cannulated
entry reamer or cannulated awl (Cat. No. 2810-01-005) (Figs. 37
and 38). Both 12 mm (Cat. No. 2810-13-001) and 13 mm (Cat.
No. 2810-13-002) entry reamers are available depending on
surgeon preference. The distal (drive end) nail diameter is 12 mm
for all nail sizes equal to or less than 12 mm, and 13 mm to 15
mm nails have a distal diameter equal to the nail diameter. Use
A/P and lateral fluoroscopic views to confirm accurate placement.
Use the awl or entry reamer to open the distal femur in the
intercondylar notch. As an option, an entry portal sleeve (Cat.
No. 2810-12-001) is available for soft tissue protection, as great
care must be taken to protect the undersurface of the patella.

Fig. 38

Note: If utilizing the cannulated entry reamer, the length of the


distal portion of the reamer is enlarged and matches the
length of the drive end portion of the nail. Fluoroscopically
verify the entry reamer has been inserted to the proper depth
that will correspond with the depth of the nail.

Fig. 39 Once access to the femoral canal has been gained,


place the ball nose guide wire into the entry site utilizing the
pistol-style guide wire gripper (Cat. No. 2810-01-001)
(Fig. 39). If preferred, a T-handle guide wire gripper
(Cat. No. 2810-01-002) is also available as an option.

Fig. 40 Fracture Reduction


Obtain appropriate anatomic reduction in order to restore
length, alignment and rotation of the injured limb. Reduction
can be achieved through the surgeon’s preferred method
such as traction and/or an external fixator. To aid in manipulating
the fracture fragments and passing the ball nose guide wire, large
(7.5 mm diameter, Cat. No. 2810-01-007) and small (6.5 mm
diameter, Cat. No. 2810-01-008) reduction tools are available
(Fig. 40). Insert the reduction tool into the medullary canal,
past the fracture site. Once the fracture is aligned, pass the
ball nose guide wire, available in both 80 cm (Cat. No. 2810-
01-080) and 100 cm (Cat. No. 2810-01-100) lengths, across
the fracture site. Remove the reduction tool.
17

RETROGRADE NAIL INSERTION


Fig. 41 Canal Preparation
Achieve proper alignment of the fracture prior to reaming
and maintain it throughout the reaming process to avoid
eccentric reaming. Initiate reaming by placing the VersaNail
Flexible Reamers over the DePuy 3.0 mm ball nose guide
wire (Fig. 41). Ream the medullary canal in millimeter
increments until cortical bone is reached and half-millimeter
increments thereafter. Surgeon preference should dictate
the actual extent of intramedullary reaming. Monitor the
reaming procedure using image intensification to avoid
eccentric or excessive cortical reaming.

Fig. 42
Nail Size Selection
An X-ray template including 10 percent
magnification is available to determine
nail size preoperatively (Cat. No. 2810-
13-025) (Fig. 42).

Nail Diameter Selection


Generally, a nail diameter 1 mm less than the final reamer diameter is chosen. Universal
Femoral Nails are available in 1 mm increments from 9 mm to 15 mm diameters.

Fig. 43 Nail Length Selection


With the tip of the ball nose guide wire at the level of the
desired depth of nail insertion, slide or snap the nail length
gauge (Cat. No. 2810-01-031) onto the ball nose guide wire
until the nose contacts the bone, ensuring the tip does not
fall into the existing entry canal, which could result in an
inaccurate measurement (Fig. 43).
18
Fig. 44 To obtain the appropriate nail length read the measurement
mark on the nail length gauge that is closest to the beginning
of the black transition area on the guide wire (Fig. 44). The
selected nail length must be at least 5 mm less than the
measured length to allow for the required recessing of the
drive end of the nail, ensuring that the nail will not protrude
into the patellofemoral joint. If the dynamization mode is to be
used at the drive end of the nail, nail length should be further
appropriately shortened. If a nail of the exact measured length
is not available, choose a shorter nail of the next closest available
length. A direct measurement can also be taken of the
uninjured extremity using either radiographs with magnification
markers, or directly on the uninjured limb.

Fig. 45 Nail/Jig Assembly


Place the nail on the femoral insertion handle in the correct
orientation. The nail should be oriented on the femoral insertion
handle such that the anterior bow of the nail is in line with the
anterior bow of the femur and the jig is lateral to the nail.
Secure the nail to the femoral insertion handle by inserting the
femoral jig bolt (Cat. No. 2810-13-008) through the cannulation
of the nose and tightening with the jig bolt driver (Cat. No.
2810-13-006) and T-handle (Cat. No. 2810-01-004) (Fig. 45).

Fig. 46 Nail Insertion


Once proper reduction has been achieved, insert the nail over
the 3 mm ball nose guide wire into the medullary canal (Fig.
46). It is important not to strike the femoral insertion handle
directly.

Fig. 47 Attach the hammer pad (Cat. No. 2810-13-011) to the


insertion handle (Fig. 47). Ensure that the hammer pad is
tightened thoroughly prior to impaction. Avoid excessive force
when inserting the nail. If the nail jams in the medullary canal,
extract it and choose the next-smaller diameter nail or
enlarge the canal appropriately.
19
Fig. 48 Note: The femoral insertion handle is marked with three
grooves (Fig. 48). The groove closest to the nail is an indicator
for the nail/insertion handle junction. A K-wire can be inserted
lateral to medial through the target arm if additional
identification of the nail/insertion handle junction is needed.
The middle groove is marked 5 mm from the top of the nail
and the groove farthest from the nail is marked 15 mm from
the top of the nail. Ensure the nail is seated to proper depth
for planned dynamization.
15 mm

5 mm
nail/jig
junction

Confirm fracture reduction and ensure appropriate nail insertion depth proximally and
distally with biplanar fluoroscopy. Remove the ball nose guide wire.

Dynamization
A dynamic slot has been incorporated in the drive end and non-drive end of the nail. The
drive end slot has a 10 mm range of dynamization. The non-drive end slot has a 5 mm
range of dynamization. If dynamization is planned, countersink the nail to the appropriate
depth to avoid backing out of the nail. Lock the M/L slot in the dynamic mode. Delayed
dynamization may be performed at a later date with the removal of the static screws.

Fig. 49 Universal Target Arm Assembly


Attach the radiolucent universal target arm (Cat. No. 2810-
13-009) onto the insertion handle, using the target arm
attachment bolt (Cat. No. 2810-13-026) and hand tighten.
Ensure the target arm is properly secured to the insertion
handle for excellent targeting (Fig. 49).
20

RETROGRADE LOCKING Locking


Prior to locking both proximally and distally, check femoral length and rotational
alignment. The nail can be locked either distally or proximally first, depending on
surgeon preference.

Fig. 50 Distal Locking


The universal target arm is marked to identify which drive end
locking option is being targeted (Fig. 50).

Fig. 51 Place 6.5 mm cortical locking screws using the black


instrumentation (Fig. 51).
Note: Depending on surgeon preference, a 6.5 mm lag
screw is also available for distal locking. If a lag locking
technique is preferred, place the 6.5 mm cancellous lag
screw using the gold instrumentation.

Fig. 52 Place the 6.5 mm screw sheath (Cat. No. 2810-13-020)


and trocar (Cat. No. 2810-13-021) through the appropriate
holes in the jig’s targeting arm to locate the incision site (Fig. 52).
Make a stab incision and advance the sheath and trocar to
the bone. Soft tissue dissection should be completed sharp
and precise to clear a path for the sheath. Undue soft tissue
tension against the sheath can cause misdirect drilling.

Fig. 53 Note: A 3.2 mm x 17.5 in guide pin (Cat. No. 9030-03-


004) and 3.2 mm pin guide sleeve (Cat. No. 2810-13-018)
can be used to verify screw position prior to drilling (Fig. 53).
21
Fig. 54 Remove the trocar and replace it with the 5.3 mm drill
sleeve (Cat. No. 2810-13-022) (Fig. 54).

Fig. 55 Utilizing the 5.3 mm drill bit (Cat. No. 2810-13-153) drill
through the drill sleeve and sheath until the far cortex is
penetrated (Fig. 55).

Fig. 56 Read the calibration on the drill bit that lines up with the
drill sleeve to determine the screw length (Fig. 56).

Fig. 57 If further screw length is required, or if the locking hole


has been initiated with a guide pin, a 6.5 mm screw depth
gauge (Cat. No. 2810-13-035) is available to read screw
length off of the 3.2 mm x 17.5 in guide pin (Fig. 57).
22
Fig. 58 Verify fluoroscopically to assure the proper screw length
selection. Remove the drill sleeve. Using the 6.5 mm
screwdriver shaft (Cat. No. 2810-13-024), insert the 6.5 mm
cortical screw through the sheath (Fig. 58). The etch mark on
the screwdriver corresponds with the screw sheath to
indicate when the screw is fully seated.

Repeat above steps for additional screw placement.

Fig. 59 Proximal Locking


Place 4.5 mm cortical locking screws using the green
instrumentation (Fig. 59).

Fig. 60 Use fluoroscopy to conduct freehand locking utilizing a


familiar freehand technique. A black radiolucent wand (Cat.
No. 2810-12-016) is available to aid in freehand locking
(Fig. 60).

Fig. 61 Accurate C-arm position is confirmed when the distal


nail hole appears to be a perfect circle (Fig. 61). Once correct
placement has been verified fluoroscopically, make a stab
wound in direct alignment with the distal hole.
23

END CAP PLACEMENT


Fig. 62 Using the 3.8 mm drill bit (Cat. No. 6 in: 2810-12-138 or Cat.
No. 8 in: 2810-13-138), drill until the second cortex is penetrated.
Verify the drill bit position fluoroscopically prior to taking any measure-
ments (Fig. 62). Place the green 4.5 mm screw length gauge (Cat. No.
2810-01-032) onto the calibrated drill bit and advance down to the
bone. Read the calibration on the drill bit that corresponds to the
measurement line indicated on the screw length gauge.

A screw depth gauge (Cat. No. 2810-01-017) is also provided for


further screw length verification. For an accurate reading, take care
to ensure the 4.5 mm screw length gauge or screw depth gauge
sheath is fully seated on the bone.

Remove the drill bit and advance the 4.5 mm screw. Repeat above
steps for additional screw placement. The SolidLok screwdriver (Cat.
Nos. 2810-01-020 and 2810-01-021) can be utilized to capture the
screw while passing it through soft tissue during screw placement.

A compensation factor is built into Fig. 63


the measurement of the screw Determining Screw Length
depth gauge (for the screw head
and cutting flutes), and the calibrated Thescrew size indicates the total measurement from the tip to the screw
drills (for the screw head only).
Depending on the surgeon
head. The calibrated drills and the screw depth gauges have a compensa-
preference for cutting tip tion factor built into the measurement such that the reading should
extension, 3-5 mm may be
added to the reading when using indicate the exact size screw to achieve bi-cortical purchase. To ensure a
the calibrated drill.
proper reading, the screw depth gauge and drill sleeves must be touching
bone. Fluoroscopy is recommended to verify the correct screw length
(Fig. 63).

Fig. 64 End Cap Placement


Impinging and non-impinging cannulated end caps are provided in
the system to both prevent bony ingrowth and add length when
needed (Fig. 64).

Fig. 65 End caps have a double hex of 5 mm and 3.5 mm and are
cannulated to accept a 3.2 mm guide pin. Place the end cap into
the end of the nail with the 4.5/5.5 mm screwdriver (Cat. No. 2810-
01-015) or the SolidLok screwdriver (Cat. Nos. 2810-01-020 and
2810-01-021) (Fig. 65). If the end cap will be placed using a 3.2
mm guide pin, place the end cap with the 5 mm hex driver (Cat.
No. 2810-01-037). Irrigate the joint to ensure that no debris
remains. Close the wound.
24

NAIL REMOVAL Fig. 66 Nail Removal


If the surgeon deems it appropriate to remove the nail, a
cannulated extractor bolt (Cat. No. 2810-01-023), used with
3/4 in hex driver (Cat. No. 2810-01-027) and T-handle
Hudson (Cat. No. 2810-01-004), is provided to aid in nail
extraction (Fig. 66).

Fig. 67Locate the top of the nail through an appropriate incision.


Remove the end cap. End caps have a double hex of 5 mm
and 3.5 mm and are cannulated to accept a 3.2 mm guide pin.

If using the guide pin method, insert the 3.2 mm guide pin
and remove the end cap using the cannulated 5 mm hex
driver (Cat. No. 2810-01-037), which is connected to the
T-handle Hudson (Cat. No. 2810-01-004) (Fig. 67).

Fig. 68 The SolidLok locking screwdriver (Cat. Nos. 2810-01-


020 and 2810-01-021) is also available to aid in removing the
end cap, if not utilizing a guide pin. Insert the SolidLok
screwdriver into the hex tip (Cat. No. 2810-01-019) and tighten
the handle to lock the end cap’s hex tip into the inner end
cap’s 3.5 mm hex (Fig. 68). The end cap can also be
removed with a standard 3.5 mm hex screwdriver.
25
Fig. 69 Make the appropriate incisions and remove all locking
screws. Remove all overgrown bone around the nail’s proximal
aspect to avoid iatrogenic fracture during nail extraction.
Once locking screws are removed, drive a 3.2 mm guide
pin into the cannulation in the nail’s proximal section. Insert
the extractor bolt over the 3.2 mm guide pin and thread it
into the nail (Fig. 69).

Fig. 70 Then thread the impactor rod into the extractor bolt and
use either the slotted mallet or sliding hammer to remove the
nail (Fig. 70).

Fig. 71 If nail removal is unobtainable utilizing the standard


extractor bolt, a conical nail extractor bolt (Cat. No. 2810-01-
022) is available for removal cases where the nail threads are
difficult to engage (Fig. 71). This instrument is designed to
work with various nail thread/cannulation designs.

Note: Nail thread/cannulation condition may limit the purchase


amount that can be gained using the conical extractor bolt.
26

ESSENTIAL PRODUCT INFORMATION IMPORTANT


This Essential Product Information does not include all of the information necessary for selection
and use of a device. Please see full labeling for all necessary information.

INDICATIONS
The use of metallic surgical appliances (orthopaedic screws, intramedullary nails, plates,
compression hip screws) provides the orthopaedic surgeon a means of bone fixation and helps
generally in the management of fractures and reconstructive surgeries. These implants are
intended as a guide to normal healing, and are NOT intended to replace normal body structure or
bear the weight of the body in the presence of incomplete bone healing. Delayed unions or
nonunions in the presence of load bearing or weight bearing might eventually cause the implant to
break due to metal fatigue. All metal surgical implants are subjected to repeated stress in use,
which can result in metal fatigue.

CONTRAINDICATIONS
Orthopaedic screws, intramedullary nails, plates, and compression hip screws are contraindicated
in: active infection, conditions which tend to retard healing such as blood supply limitations,
previous infections, insufficient quantity or quality of bone to permit stabilization of the facture
complex, conditions that restrict the patient’s ability or willingness to follow postoperative
instructions during the healing process, and foreign body sensitivity.

ADDITIONAL CONTRAINDICATIONS FOR INTRAMEDULLARY NAILS ONLY


Cases where the nail would cross open epiphyseal plates in skeletally immature patients and
obliterated medullary canal or other conditions which tend to retard healing such as blood
supply limitations, or previous infections.

ADDITIONAL CONTRAINDICATION FOR RETROGRADE FEMORAL NAILING


A history of septic arthritis of the knee and knee extension contracture with inability to attain at
least 45º of flexion.

WARNINGS AND PRECAUTIONS


Bone screws and pins are intended for partial weight bearing and non-weight bearing
applications. These components cannot be expected to withstand the unsupported stresses
of full weight bearing.

ADVERSE EVENTS
The following are the most frequent adverse events after fixation with orthopaedic screws,
intramedullary nails, plates and compression hip screws: loosening, bending, cracking or fracture
of the components or loss of fixation in bone attributable to nonunion, osteoporosis, markedly
unstable comminuted fractures; loss of anatomic position with nonunion or malunion with rotation
or angulation; infection and adverse reactions to the device material.
27

IMPLANTS
UNIVERSAL PLATFORM
Femoral Universal Nail 9 mm Femoral Universal Nail 13 mm 6.5 mm Self Tapping Cortical
28-50 cm 28-50 cm Screws Full Thread (Drive End)
Cat. No. Description Cat. No. Description Cat. No. Description
1813-09-280 9 mm x 28 cm 1813-13-280 13 mm x 28 cm 1020-40 40 mm Length
1813-09-300 9 mm x 30 cm 1813-13-300 13 mm x 30 cm 1020-45 45 mm Length
1813-09-320 9 mm x 32 cm 1813-13-320 13 mm x 32 cm 1020-50 50 mm Length
1813-09-340 9 mm x 34 cm 1813-13-340 13 mm x 34 cm 1020-55 55 mm Length
1813-09-360 9 mm x 36 cm 1813-13-360 13 mm x 36 cm 1020-60 60 mm Length
1813-09-380 9 mm x 38 cm 1813-13-380 13 mm x 38 cm 1020-65 65 mm Length
1813-09-400 9 mm x 40 cm 1813-13-400 13 mm x 40 cm 1020-70 70 mm Length
1813-09-420 9 mm x 42 cm 1813-13-420 13 mm x 42 cm 1020-75 75 mm Length
1813-09-440 9 mm x 44 cm 1813-13-440 13 mm x 44 cm 1020-80 80 mm Length
1813-09-460 9 mm x 46 cm 1813-13-460 13 mm x 46 cm 1020-85 85 mm Length
1813-09-480 9 mm x 48 cm 1813-13-480 13 mm x 48 cm 1020-90 90 mm Length
1813-09-500 9 mm x 50 cm 1813-13-500 13 mm x 50 cm 1020-95 95 mm Length
1020-100 100 mm Length
Femoral Universal Nail 10 mm Femoral Universal Nail 14 mm
28-50 cm 28-50 cm (Special Order Only) 6.5 mm Solid Cancellous Lag Screws
Cat. No. Description Cat. No. Description (Drive End)
1813-10-280 10 mm x 28 cm 1813-14-280 14 mm x 28 cm Cat. No. Description
1813-10-300 10 mm x 30 cm 1813-14-300 14 mm x 30 cm 1030-60 60 mm Length
1813-10-320 10 mm x 32 cm 1813-14-320 14 mm x 32 cm 1030-65 65 mm Length
1813-10-340 10 mm x 34 cm 1813-14-340 14 mm x 34 cm 1030-70 70 mm Length
1813-10-360 10 mm x 36 cm 1813-14-360 14 mm x 36 cm 1030-75 75 mm Length
1813-10-380 10 mm x 38 cm 1813-14-380 14 mm x 38 cm 1030-80 80 mm Length
1813-10-400 10 mm x 40 cm 1813-14-400 14 mm x 40 cm 1030-85 85 mm Length
1813-10-420 10 mm x 42 cm 1813-14-420 14 mm x 42 cm 1030-90 90 mm Length
1813-10-440 10 mm x 44 cm 1813-14-440 14 mm x 44 cm 1030-95 95 mm Length
1813-10-460 10 mm x 46 cm 1813-14-460 14 mm x 46 cm 1030-100 100 mm Length
1813-10-480 10 mm x 48 cm 1813-14-480 14 mm x 48 cm 1030-105 105 mm Length
1813-10-500 10 mm x 50 cm 1813-14-500 14 mm x 50 cm 1030-110 110 mm Length
1030-115 115 mm Length
Femoral Universal Nail 11 mm Femoral Universal Nail 15 mm 1030-120 120 mm Length
28-50 cm 28-50 cm (Special Order Only)
Cat. No. Description Cat. No. Description 4.5 mm Self Tapping Cortical Screws
1813-11-280 11 mm x 28 cm 1813-15-280 15 mm x 28 cm Full Thread (Non-Drive End)
1813-11-300 11 mm x 30 cm 1813-15-300 15 mm x 30 cm Cat. No. Description
1813-11-320 11 mm x 32 cm 1813-15-320 15 mm x 32 cm 14022-24 24 mm Length
1813-11-340 11 mm x 34 cm 1813-15-340 15 mm x 34 cm 14022-28 28 mm Length
1813-11-360 11 mm x 36 cm 1813-15-360 15 mm x 36 cm 14022-32 32 mm Length
1813-11-380 11 mm x 38 cm 1813-15-380 15 mm x 38 cm 14022-36 36 mm Length
1813-11-400 11 mm x 40 cm 1813-15-400 15 mm x 40 cm 14022-40 40 mm Length
1813-11-420 11 mm x 42 cm 1813-15-420 15 mm x 42 cm 14022-44 44 mm Length
1813-11-440 11 mm x 44 cm 1813-15-440 15 mm x 44 cm 14022-48 48 mm Length
1813-11-460 11 mm x 46 cm 1813-15-460 15 mm x 46 cm 14022-52 52 mm Length
1813-11-480 11 mm x 48 cm 1813-15-480 15 mm x 48 cm 14022-56 56 mm Length
1813-11-500 11 mm x 50 cm 1813-15-500 15 mm x 50 cm 14022-60 60 mm Length
14022-65 65 mm Length
Femoral Universal Nail 12 mm End Caps 14022-70 70 mm Length
28-50 cm Cat. No. Description 14022-75 75 mm Length
Cat. No. Description 1813-00-005 End Cap 14022-80 80 mm Length
1813-12-280 12 mm x 28 cm Universal 5 mm
1813-12-300 12 mm x 30 cm 1813-00-010 End Cap
1813-12-320 12 mm x 32 cm Universal 10 mm
1813-12-340 12 mm x 34 cm 1813-00-015 End Cap
1813-12-360 12 mm x 36 cm Universal 15 mm
1813-12-380 12 mm x 38 cm Indicates outlier size not included
1813-00-002 End Cap in standard set configuration.
1813-12-400 12 mm x 40 cm Universal Impinging
1813-12-420 12 mm x 42 cm 1813-00-001 End Cap Indicates special orders only.
1813-12-440 12 mm x 44 cm Universal Flush Not an inventory item.
1813-12-460 12 mm x 46 cm
1813-12-480 12 mm x 48 cm
1813-12-500 12 mm x 50 cm
28

INSTRUMENT CATALOG NUMBERS AND DESCRIPTIONS 2810-01-001


2810-01-002
2810-01-003
Pistol Guidewire Gripper
T-Handle Guidewire Gripper (optional)
Slotted Mallet
1
2
3
1 2

GENERAL
2810-01-004 T-Handle Hudson 4
3 4

2810-01-005 Curved Cannulated Awl 5 5 10


2810-01-025 Awl Stylus 6
2810-01-026 Guidewire Pusher 7
2810-13-001 12 mm Entry Reamer, Femur 8
2810-13-002 13 mm Entry Reamer, Femur 9 6 11
CANAL PREP

2810-13-004 Entry Portal Trocar 10


2810-13-005 Long Entry Portal 11
2810-01-007 Long Reduction Tool 12
7
2810-01-008 Short Reduction Tool 13
8 12

9 13

1186 3/4 in Combination Wrench 14 15 19


2810-13-006 Jig Bolt Driver, 8 mm 15
2810-13-007 Femoral Insertion Handle 16
16 20
NAIL INSERTION

2810-13-008 Femoral Jig Bolt 17


2810-13-009 Universal Target Arm 18
2810-13-011 Hammer Pad Femur 19
2810-13-026 Target Arm Attachment Bolt 20
1095 Impactor Rod/Extraction 21 17 21
1096 Sliding Hammer 22

14 18 22

2810-13-018 3.2 mm Guide Pin Sleeve - Silver 23 23 27


PROMIXAL LOCKING

2810-13-020 6.5 mm Screw Sheath 24


2810-13-021 6.5 mm Screw Trocar 25
2810-13-022 5.3 mm Drill Sleeve - Black 26 24 28
2810-13-023 6.5/4.8 mm Step Drill Sleeve - Gold 27
2810-13-024 6.5 mm Screwdriver Shaft 28
25 29
2810-13-035 6.5 mm Screw Depth Gauge 29
2141-49-000 AO Quick Couple Screwdriver 30
26 30

2810-12-016 Freehand Distal Targ. Dev. 31 34


DISTAL LOCKING

Universal - Black 31
2810-01-015 4.5/5.5 mm Screwdriver Shaft 32
2810-01-032 4.5 mm Screw Length Gauge 33 32 35
2810-01-017 Screw Depth Gauge 34
2810-01-020 SolidLok Screwdriver Handle 35
2810-01-021 SolidLok Driver Inner Shaft 36
33 36
29

2810-01-023 Extractor Bolt, Tibia/Femur 37 37


NAIL REMOVAL 2810-01-022 Conical Extractor Tool 38
2810-01-027 3/4 in Hex Driver 39 38
39

14012-14 3.2 mm x 14 in Short Threaded Guide Pin 40 44


9030-03-004 3.2 mm x 17 1/2 in Threaded Guide Pin 40
2810-01-019 SolidLok Hex Tip, 3.5 mm 41
41 45
DISPOSABLES

2810-01-100 Ball Nose Guide Wire 100 cm 42


2810-12-138 3.8 mm Drill Bit 6 in, Non-sterile 43
2810-13-138 3.8 mm Drill Bit 8 in, Non-sterile 44
2810-13-153 5.3 mm Drill Bit, Non-sterile 45 42 46
2810-13-165 6.5/4.8 mm Step Drill Bit, Non-sterile 46

43

2810-13-030 Femoral Tray Entry & Jigs 47 49 50 51


2810-13-031 Femoral Tray Locking & Extraction 48
8299-10-500 Modular Screw System Outer Case 49
8299-10-045 4.5 mm Cort Screw Module 50
8299-10-065 6.5 mm Screw Module 51
CASES & TRAYS

Screw
47 48 Modules

Outer Case

1245 Radiographic Ruler 52 52


2810-01-031 Nail Length Gauge, 14 mm 53
2810-13-025 VersaNail Femoral Universal 53
NAIL MEASUREMENT

Template 54

54

55
ENDCAP PLACEMENT

2810-01-037 5.0 mm Hex Driver, Long 55


FEMORAL UNIVERSAL NAILING SYSTEM
0 mm 12 mm Drive End Diameter
12 mm drive end for 9-12 mm Nails
accommodates 14 mm Drive End Diameter Equal to Nail Diameter
for 13-15 mm Nails
6.5 mm screws 6.4 cm
29 mm
10 mm Dynamization Range
39 mm
Large core diameter
of 6.5 mm screws 54 mm
decreases risk for
screw breakage

Universal design allows one nail for either


antegrade or retrograde application to
treat right- or left-sided fractures

Enlarged nail cannulation accepts the


ball nose guide wire, eliminating
the need for an exchange tube

2.2 meter radius of curvature


accommodates the anterior bow
of the femur

Dynamization options available


proximally and distally allowing
compression at the fracture site

Distal locking options to treat a


greater range of fracture patterns

Large core diameter of 4.5 mm


48 mm
non-drive end screws decreases
the risk of screw breakage 38 mm
28 mm
18 mm
Bullet-style tip increases ease 5 mm
13 mm Dynamization
of insertion
Range
0 mm

For more information about DePuy products, visit our web site at www.jnjgateway.com.

6M0106 Printed in USA.


0612-59-502 ©2006 DePuy Orthopaedics, Inc. All rights reserved.

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