Pedi Nail Surgical Technique ST 1500 01 Rev A

2015-05-29

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PediNail™ Pediatric Femoral Nail
SURGICAL TECHNIQUE

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PediNail™

TABLE OF CONTENTS

Indications ........................................................................ 6
Proximal Locking Options ................................................................... 6

PediNail™

System Overview

Distal Locking Options ......................................................................... 6
Preoperative Planning .......................................................................... 7
Nail Size Selection ................................................................................. 7
Entry Point and Entry Angle ................................................................ 8

Surgical Technique
Patient Positioning .............................................................. 9
Approach ............................................................................................... 10
Measuring .............................................................................................. 18
Reaming Technique .............................................................................. 21
Nail Placement ...................................................................................... 23
Proximal Interlocking .......................................................... 26
Distal Interlocking .............................................................. 29
Closure & Post-Operative Care ............................................ 31
Nail Removal ..................................................................... 32

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TABLE OF CONTENTS

Product Information
Left Femur Implants ......…...............................……...……... 35
Left XL Femur Implants ................................................................... 35
Right Femur Implants ............................................... . ...... 37
Right XL Femur Implants ................................................................. 38
IM Nail End Cap ................................................................................ 39
4.0mm Cortical Screws ................................................................... 39
4.5mm Cortical Screws .…..……….....…......….................…… 40
Tissue Protectors .............................................................................. 41
Reamer Heads .................................................................................... 41
Reamer Shafts .................................................................................... 41
Drills ..................................................................................................... 41
Guide Wires ........................................................................................ 42
Guide Tubes ........................................................................................ 42
Hex Drivers ......................................................................................... 42
PediNail Instrumentation .….....………….……….........….......... 43

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PediNail™

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PediNail™

INDICATIONS
The OrthoPediatrics PediNail™ System is designed for use in pediatric and small stature adult patients to address
femoral shaft fractures, subtrochanteric femur fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions, malunions, and fixation of femurs that have been surgically prepared
(osteotomy) for correction of deformity.
Additional indications include simple long bone fractures, severely comminuted fractures, spiral fractures, large
oblique and segmental fractures, polytrauma and multiple fractures, reconstruction following tumor resection and
bone grafting, supracondylar femur fractures, bone lengthening and shortening, fixation of fractures that occur in
and between the proximal and distal third of the long bones being treated.
The OrthPediatrics PediNail™ System is available in 7mm, 8mm, 9mm, and 10mm diameters and lengths from 20cm
to 42cm depending on the nail diameter.
Screw interlocking options are available both proximally and distally.
Proximal Locking Options:
•	 The proximal locking options for the 7mm nail include a single 4.5mm screw placed from the greater trochanter
to the lesser trochanter and a single 4.5mm reconstruction screw placed into the femoral neck.
•	 The proximal locking options for the 8mm nail include a single 4.5mm screw placed from the greater trochanter
to the lesser trochanter and a single 4.5mm reconstruction screw placed into the femoral neck.
•	 The proximal locking options for the 9mm nail include a single 4.5mm screw placed from the greater trochanter
to the lesser trochanter and a single 4.5mm reconstruction screw placed into the femoral neck. In addition, the
proximal locking options for the 9mm nail include a single transverse 4.5mm screw distal to the greater/lesser
and reconstruction screw.
•	 The proximal locking options for the 10mm nail include a single 4.5mm screw placed from the greater
trochanter to the lesser trochanter and a single 4.5mm reconstruction screw placed into the femoral neck. In
addition, the proximal locking options for the 10mm nail include a single transverse screw distal to the greater/
lesser and reconstruction screw.
Distal Locking Options:
•	 The distal locking options for the 7mm nail include a single anterior to posterior 4.0mm locking screw and two
lateral to medial 4.0mm locking screws.
•	 The distal locking options for the 8mm nail include a single anterior to posterior 4.5mm locking screw and two
lateral to medial 4.5mm locking screws.
•	 The distal locking options for the 9mm nail include a single anterior to posterior 4.5mm locking screw and two
lateral to medial 4.5mm locking screws.
•	 The distal locking options for the 10mm nail include a single anterior to posterior 4.5mm locking screw and two
lateral to medial 4.5mm locking screws.
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Note: The 4.0mm locking screw is only used for distal locking of the 7mm nail.

SYSTEM OVERVIEW

Effective preoperative planning allows the surgeon to predict the impact of different interventions in order to
perform the correction in the most accurate and safest manner. Optimal intramedullary nail fit, landmarking for entry
point, entry angle, and assessment of alignment and rotation can be evaluated through preoperative radiographic
analysis. Preoperative planning also allows the surgeon to have the appropriate implants available at the time of
surgery.

PediNail™

PREOPERATIVE PLANNING

The objectives of preoperative planning include:
1.	 Determination of anticipated nail diameter and nail length.
2.	 Establishment of appropriate anatomic landmarks, including the greater and lesser trochanters and physes.
The overall objective of preoperative planning is to enable the surgeon to gather anatomic parameters which will
allow accurate intra-operative placement of the implant.

NAIL SIZE SELECTION
Choosing the appropriate nail diameter and length are crucial to a successful surgical procedure. When selecting
the diameter of the intramedullary nail to be used, it is not necessary to fill the entire intramedullary canal to
achieve a tight isthmic fit with the nail. Generally speaking, an 8mm diameter nail is sufficient for most children and
adolescents. In smaller patients, a 7mm nail may be used, and in larger patients a 9mm or 10mm nail may be used.
1

Note: The 7mm and 8mm nails do not allow for proximal transverse locking bolt fixation. This should be taken into
consideration when preoperatively planning.

Choosing the length of the nail can be done intraoperatively using the nail measuring gauge. After passing the
2.7mm Ball Tipped Reaming Rod into the distal fragment, a direct measurement can be made with the Nail
Measuring Guide.
Alternatively, use the OrthoPediatrics PediNail templates to estimate nail length and diameter. To estimate nail
diameter, place the template on the AP or lateral x-ray of the femur and measure the diameter of the medullary canal
at the isthmus.
To estimate nail length, place the template on the AP x-ray of the uninjured femur and select the appropriate nail
length based on patient anatomy.
Additionally, the 2.7mm Ball Tipped Reaming Rod and the 2.0mm Guide Insertion Wire can be used to measure nail
length, since they are equal in length (810mm). With either of the rods in place (gently seated in the distal femoral
metaphysis), a measurement can be taken by placing the other rod adjacent to the rod inside the canal. Using a
hemostat, clip the second rod (the one outside the femoral canal) at the end of the rod extending from the canal.
Use the measuring gauge on the inside surface of the sterilization lid.
2

Note: When selecting nail size, consider canal diameter, fracture pattern, patient anatomy and postoperative
protocol.

Templates are available in 115% magnification in which the image is enlarged 15% to correspond to typical radiographic magnification; however, variations in magnification levels are common.

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ENTRY POINT AND ENTRY ANGLE
The PediNail™ intramedullary nail system is designed for use with a lateral trochanteric entry point for two reasons:
1.	 To avoid the piriformis fossa and subsequently the blood vessels of the medial circumflex artery supplying blood
to the head of the femur, thus reducing the likelihood of iatrogenic femoral head avascular necrosis.
2.	 To avoid tethering the trochanteric growth plate, decreasing the risk of femoral neck narrowing and hip valgus.
The 15° proximal bend allows the entry point to be approximately 1 finger breadth lateral to the tip of the greater
trochanter. The entry angle is measured from the entry point to a point inferior to the lesser trochanter (Figure 1).

FIGURE 1: Entry point and entry angle

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SURGICAL TECHNIQUE

First, place the patient on a fracture table in the supine position.

PediNail™

PATIENT POSITIONING

Apply traction to the affected limb using a well-padded boot. Slightly externally rotate the limb to match the
proximal fragment which tends to externally rotate slightly when the patient is positioned on the fracture table.
Prep and drape the lower extremity using split sheets to allow circumferential access to the thigh. Cover the
image intensifier with a sterile drape to visualize the hip and femur (Figure 2).
The proximal femur can be best visualized by arcing the image intensifier so the beam is directed from
posteromedial to anterolateral. This allows the surgeon to see the externally rotated proximal femur in a nonrotated AP projection.

FIGURE 2: Patient positioning

1

Note: Alternatively, the patient may be positioned supine on a radiolucent table. The limb (or both limbs in
the case of bilateral procedures) can be prepared and draped free. This facilitates simultaneous irrigation and
debridement of open femur fractures, bilateral derotation osteotomy, or fixation of an ipsilateral tibial fracture.
In order to bring the fracture out to length, an assistant may be required to apply manual traction.

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1
APPROACH
Place the 3.2mm Threaded Tipped Guide Wire percutaneously
through the lateral aspect of the greater trochanter at a point
approximately halfway between the tip of the trochanter and the
trochanteric physis (Figure 3).
Drive the 3.2mm Threaded Tipped Guide Wire under power with
a drill through the trochanteric physis and into the medullary canal
up to, but not through, the medial aspect of the proximal femur at
an angle inferior to the lesser trochanter.
The 3.2mm Threaded Tipped Guide Wire should be 1.0-1.5cm
distal to the lesser trochanter at an angle of 10-15° from the
femoral shaft axis.

FIGURE 3: Insert Guide Wire into lateral
aspect of greater trochanter
Check a lateral radiograph to insure that the 3.2mm Threaded
Tipped Guide Wire is in the center of the femoral canal and is
not inserted too shallow or too steep
1

Note: Inspect pins and wires for any damage prior to use.
Utilizing damaged instruments may adversely affect the
outcome of the procedure.

FIGURE 4: Lateral radiograph to ensure
position in center of femoral canal

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PediNail™

Create a 1.5cm incision proximal to the 3.2mm Threaded Tipped
Guide Wire entry site, passing the scalpel adjacent to the guide
wire, down to the trochanter (Figure 5).

FIGURE 5: 1.5cm incision proximal to the
3.2mm Threaded Tipped Guide Wire entry site

Place either a 10mm or a 12mm Tissue Protector over the 3.2mm
Threaded Tipped Guide Wire and into the soft tissue to protect
the surrounding skin and soft tissue while using the opening
reamer (Figure 6).

FIGURE 6: Place Tissue Protector over the
3.2mm Threaded Tipped Guide Wire and into
soft tissue

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Advance the 9.5mm Cannulated Entry Reamer over the 3.2mm
Threaded Tipped Guide Wire through the trochanter into the
femoral canal (Figures 7-9).

FIGURE 7: Advance 9.5mm Cannulated Entry
Reamer over 3.2mm Threaded Tipped Guide
Wire

FIGURE 8: AP radiograph to confirm
placement in femoral canal and starting point

FIGURE 9: AP radiograph to check reamer

CAUTION:
Do not advance the guide wire or entry reamer past the medial femoral cortex.

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Withdraw the 9.5mm Cannulated Entry Reamer, leaving the
3.2mm Threaded Tipped Guide Wire in place in the proximal
femur (Figure 10).

FIGURE 10: Withdraw 9.5mm Cannulated
Entry Reamer

1

Note: If the 3.2mm Threaded Tipped Guide Wire appears to be lodged in the 9.5mm Cannulated Entry
Reamer, use the Obturator to ensure that the Guide Wire remains in place upon removal of the reamer.

2

Note: Refer to Section 3: Reaming Technique (Reamer Use Guidelines).

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Replace the 10 or 12mm Tissue Protector with the 7mm
Exchange Tube (Figure 11).
Place the 7mm Exchange Tube into the femoral canal and
withdraw the 3.2mm Threaded Tipped Guide Wire (Figures
12 & 13 ).

FIGURE 11: Replace Tissue Protector with
7mm Exchange Tube

FIGURE 13: Leave Exchange Tube in place
and withdraw the guide wire

FIGURE 12: Verify placement of 7mm
Exchange Tube

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Leaving the 7mm Exchange Tube in place, insert the 2.7mm Ball
Tipped Reaming Rod (Figure 14). Check placement on radiograph
(Figure 15).

FIGURE 14: Insert 2.7mm Ball Tipped
Reaming Rod

FIGURE 15: Check placement on radiograph

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PediNail™

Advance the 2.7mm Ball Tipped Reaming Rod to the
femur to the level of the fracture (Figure 16). Using
a radiograph, verify placement of the Ball Tipped
Reaming Rod (Figures 17a & 17b).

FIGURE 16: Pass 2.7mm Ball Tipped
Reaming Rod to the level of the
fracture

FIGURE 17a: Check
for placement at the
level of the fracture

16 16

FIGURE 17b: Check
for placement at the
level of the fracture

PediNail™

Remove the 7mm Exchange Tube and reduce the fracture. If it is difficult to pass the 2.7mm Ball Tipped Reaming Rod
across the fracture site, use the Reduction Tool to assist in passing the 2.7mm Ball Tipped Reaming Rod.
After the fracture is reduced, pass the 2.7mm Ball Tipped Reaming Rod into the distal femur and impact it into the
lateral femoral metaphysis to a depth of approximately 1cm proximal to the distal femoral physis (Figures 18a & 18b).
1

Note: Verify placement using AP and ML fluoroscopy to ensure 2.7mm Ball Tipped Reaming Rod is in the distal
fragment.
CAUTION:
Do not advance 2.7mm Ball Tipped Reaming Rod into physis or joint space.

FIGURES 18a & 18b: Pass 2.7mm Ball Tipped Reaming Rod into
the distal femur

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2
MEASURING
Prior to reaming, measure for the nail. When determining
nail length, take care to accommodate for any distraction
at the fracture site as well as the position of the 2.7mm
Ball Tipped Reaming Rod or guide wire in the distal femur
to avoid penetration of the distal femoral physis by the
nail.
Place the Measurement Gauge over the 2.7mm Ball
Tipped Reaming Rod (Figures 19 & 20).
1

Note: It is advisable to verify nail length using a second
measurement method (i.e. two equal length reaming
rods or confirmation with nail scale, found on the inside
of tray lid). If the guide wire is not visible in the window,
the 42mm length nail should be selected.

FIGURE 19: Place Measurement Guide over
2.7mm Ball Tipped Reaming Rod

FIGURE 20: Measure for nail

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Insert the Measurement Gauge into the reamed hole to the appropriate depth. Keep in mind that the nail will usually
be countersunk approximately 5mm (Figure 21).
Select a potential nail. Use the desired nail length to assess the nail diameters that could be used.

Nail Length

Nail Diameter

20cm - 30cm Standard

7mm

32cm - 38cm XL

7mm

24cm - 36cm Standard

8mm

38cm - 42cm XL

8mm

28cm - 38cm Standard

9mm

40cm - 42cm XL

9mm

30cm - 42cm Standard

10mm

FIGURE 21: Insert Measurement Gauge into reamed
hole

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Protect the skin at the incision site by sliding the Soft
Tissue Protector over the 2.7mm Ball Tipped Reaming Rod
and passing it down into the soft tissue (Figure 22).

FIGURE 22: Protect skin at incision site with Soft
Tissue Protector

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For most patients, utilize the flexible shaft with detachable side cutting reamer heads from 7.5mm to 12.0mm.

PediNail™

3
REAMING TECHNIQUE (REAMER USE GUIDELINES)
Under power, advance the reamer into the femoral canal. Keep advancing the reamer the entire length of the
femur in a forward motion, up and down the entire length of the femur.
CAUTION:
•	 ALWAYS FORWARD. Use power tool in the forward setting at
all times.
•	 ALWAYS ON. Do not stop the power tool.
Using fluoroscopy, confirm that the reamer has reached the distal end of the 2.7mm Ball Tipped Reaming Rod.
1

Note: Frequently clean the reamer flutes to prevent clogging.

If the reamer becomes stuck in the femoral canal, grasp the 2.7mm Ball Tipped Reaming Rod with a large needle
holder or vise grip and withdraw it 1 to 2cm while attempting to advance the reamer under power. If the reamer
continues to be immovable, grasp the reaming rod with a large needle holder or vise grip and using a mallet tap on
the vise grip in a retrograde manner in order to remove the reamer and guide wire together.
CAUTION:
Never reverse the reamer, as this could lead to reamer shaft failure.
Switch to the detachable side cutting reamers at size 7.5mm and continue reaming to desired diameter.
2

Note: It is not necessary to “fill” the canal or to continue reaming until “chatter” is noted. Appropriate selection of
nail diameter is not dependent upon getting a tight fit in the isthmus of the femur.
CAUTION:
Do not ream past the distal bend in the 2.7mm Reaming Rod, as this may cause the reamer to bind and/or rupture.
WARNING:
When performing a femoral osteotomy, to reduce the likelihood of pulmonary emboli, prepare the osteotomy prior to
reaming or create vent holes in the femur.
CAUTION:
For 6mm, 6.5mm, 7.0mm one piece front cutting reamers:
•	 Start with the 6mm reamer and go up in 0.5mm increments.
•	 Do not use in hard cortical bone.
•	 Recommended to over-ream 1 to 1.5mm over desired implant diameter.

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PediNail™

Place the Exchange Tube over the 2.7mm Ball Tipped Reaming Rod
and insert into the reamed femoral canal (Figure 23). Verify placement
on radiograph (Figure 24).
Remove the 2.7mm Ball Tipped Reaming Rod and replace with the
2.0mm Guide Insertion Wire (Figures 25a & 25b).
Remove the Exchange Tube.
1

Note: Removal of the 2.7mm Ball Tipped Reaming Rod without
placement of the Exchange Tube or 2.0mm Guide Insertion Wire may
result in loss of reduction.

FIGURE 23: Place Exchange Tube
over Ball Tipped Reaming Rod

CAUTION:
If nail is implanted over 2.7mm Ball Tipped Reaming Rod, the reaming
rod will not be able to be removed.

FIGURE 24: Verify placement

FIGURE 25a: Remove Ball Tipped
Reaming Rod

FIGURE 25b: Insert 2.0mm Guide
Insertion Wire

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Attach the pre-selected nail to the Targeting Device with the Attachment Bolt (Figures 26a & 26b).

PediNail™

4
NAIL PLACEMENT

CAUTION:
Be certain that the attachment bolt remains tight throughout the impaction process. Failure to do so may lead
to bolt breakage.
CAUTION:
Attachment Bolt is a single-use device. It may be used to perform a bi-lateral procedure on a single patient.

FIGURES 26a & 26b: Attach nail to Targeting Device with
Attachment Bolt
1

Note: Use the Ball Hex Driver to perform final tightening of components prior to insertion of the nail.

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PediNail™

Prior to insertion of the nail, check alignment to ensure
accurate targeting of the nail through the jig. Insert the
outer and inner guide tubes and drill bit and make sure
the drill bit is in line with the interlocking holes in the nail
(Figure 27).
Attach the Impaction Rod to the threaded hole in the
targeting device for impaction of the nail.
1

Note: Be certain that the impaction rod is fully seated
with the flange on the impaction rod resting on the
targeting guide. Maintain tightness and flange to
targeting guide contact throughout the impaction
process.

Carefully pass the nail over the 2.0mm Guide Insertion
Wire and into the femoral canal to maintain location of
the canal opening and to ease in insertion of the nail.
Be sure that the nail slides freely over the guide wire to
prevent advancement of the guide wire distally. Using
controlled strikes with the mallet, drive the nail into the
distal femur.
2

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Note: If advancement of the nail is difficult,
remove the nail and ream another 0.5mm. It is
common to over ream the canal by 1-1.5mm.

FIGURE 27: Confirm that nail is oriented correctly

PediNail™

Impact the nail to approximately 5mm below the level of
the trochanter but proximal to the trochanteric physis.
After the nail is inserted to the appropriate depth, remove
the 2.0mm Guide Insertion Wire (Figures 28 & 29).
1

Note: Failure to remove Smooth Guide Wire may result in
instrumentation damage and metal debris.

FIGURE 28: Impact the nail

FIGURE 29: Check position of nail impaction

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5
PROXIMAL INTERLOCKING
Insert the Outer Guide Tube and Inner Guide Tubes into
the Targeting Device and push down to the skin (Figure
30).
1

Note: Do not apply excessive force to the targeting
construct or targeting might be compromised.

Mark the skin with the drill sleeves and make a longitudinal
incision. Bluntly dissect down to bone.
2

Note: Carefully remove the inner C-springs and clean
thoroughly. Be sure to replace the inner C-springs after
cleaning. If the inner C-springs are missing from the guide
tubes, the tubes will not be self-retaining.

Make sure the inner and outer guide tubes are advanced to
the lateral cortex of the femur. Failure to do so will effect
proximal screw measurement and insertion.

FIGURE 30: Insert Outer Guide Tube and Inner Guide
Tube into Targeting Device

Blue Guide Tubes = 3.5mm
Green Guide Tubes = 4.5mm

Optional: Use the Trocar and light blows with a
mallet to make a notch in the lateral cortex of the
femur. This is done to ensure that the drill bit does
not slip off the cortex (“skyve”) while drilling (Figure
31).

FIGURE 31: Use Trocar and Mallet to make a notch
in lateral cortex (Optional)

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Remove the central trocar and insert the 3.2mm Calibrated
Drill Bit. Drill through the near cortex (Figure 32).
When the far cortex is reached, stop and measure from the
calibration on the drill bit.

FIGURE 32: Insert Calibrated Drill Bit through the
near cortex

Advance the 3.2mm Drill Bit through the far cortex. Detach
the drill bit from the drill and leave in place while selecting
the appropriate screw.
Remove the 3.2mm Drill Bit and inner guide tube. Insert
the screw through the outer guide tube and into the bone.
Tighten the screw and remove the outer drill sleeve.
Verify screw position and length on AP and lateral image
intensification (Figure 33).
1

Note: If it is necessary to re-engage the screwdriver into
the screw head, it is recommended that the Inner Guide
Tube is reinserted into the Targeting Device first.

FIGURE 33: Verify screw position and length

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PediNail™

If a recon screw is to be used, place the outer and inner
drill sleeves into the appropriate guide and make a skin
incision in line with the trajectory of the guide.
Advance the drill sleeves through the soft tissue, onto the
bone. Be sure to notch the cortex with the trocar before
drilling.
Drill with the calibrated 3.2mm Drill Bit and measure.
Insert the appropriate length screw (Figure 34).
If resistance is encountered during screw insertion,
remove the screw and drill the outer cortex with the
4.5mm drill. Insert the screw.

FIGURE 34: Preparation of recon screw

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6
DISTAL INTERLOCKING
Distal interlocking is carried out using the free hand technique
(Figure 35).
Check rotation and length carefully prior to placing interlocking
screws by examining the patient and examining the fracture site
radiographically.

FIGURE 35: Free
hand perfect circle
distal interlocking
Place the image intensifier so that the interlocking hole makes
a perfect circle in the center of the fluoroscopy monitor screen
(Figure 36).

FIGURE 36: Verify
position of perfect
circle with drill bit

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PediNail™

Make an incision over the center of the hole on either
the anterior or lateral distal thigh depending on which
interlocking hole has been selected. Dissect bluntly
through the soft tissue down to bone and position the
drill bit over the center of the hole. Drill through both
cortices and disconnect the drill bit from the drill. Check
radiographically to ensure that the drill bit has passed
through the nail.
Remove the drill bit from the hole and insert the depth
gauge. Slide the hook of the depth gauge through the
drilled hole and grab the far cortex with the hook. Slide
outer sleeve against the near cortex and measure.
Measure for the screw. Leaving the depth gauge in place,
select the appropriate screw.
When the appropriate screw is ready, remove the depth
gauge and insert the screw through the outer guide tube.
Check the screw for proper placement and length on AP
and lateral image intensification. Verify radiographically
(ML/AP) that screw is in distal locking hole of nail (Figure
37).
Repeat if two distal screws are desired.
If using a 4.0mm distal locking screw, utilize the 2.9mm
Short Drill Bit. If using a 4.5mm distal lock screw, utilize
the 3.2mm Short Drill Bit.
If an End Cap is desired, reinsert the 2.0mm Guide
Insertion Wire into the proximal portion of the nail. (This
can be done before or after the targeting arm is removed.)
Place the End Cap onto the Cannulated Screwdriver and
pass it over the 2.0mm Guide Insertion Wire. Screw the
End Cap into the nail.

30 30

1

Note: The 0mm End Cap is not cannulated and must be
inserted without the 2.0mm Smooth Guide Wire.

2

Note: Do not final tighten End Cap with cannulated
T-handle. Do not impact cannulated T-handle. Perform
final tightening with Ball Hex Driver.

FIGURE 37: Check the screw for proper
placement and length

Confirm position of the nail and all locking screws. After confirmation is complete, remove the targeting device.
Check for motion at the fracture site and rotational stability.

PediNail™

7
CLOSURE AND POST-OPERATIVE CARE

Irrigate and close the surgical wounds in layers.
If adequate fixation has been achieved, no cast immobilization is required. The patient can be allowed toe-touch
weight bearing or weight bearing as tolerated on crutches or a walker depending on the patient size and fracture
stability.

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8
NAIL REMOVAL
1

Note: For nail removal, the Bullet Tipped Extractor or
Extraction Bolt may be used. The Bullet Tipped Extractor
is not standard in the PediNail™ set. If the Bullet Tipped
Extractor is to be used, contact Customer Service prior to
nail removal.

2

Note: If a 0mm End cap is used, it must be removed prior
to inserting the Guide Wire.

3

Note: The Bullet Tipped Extractor and the Extraction Bolt
undergo significant stress when removing intramedullary
nails. It is recommended that these items be used once
and discarded.

Intramedullary nail removal, if desired, should be deferred, if
possible, until after closure of the trochanteric physis (usually
by age 13 to 14). For nail removal, position the patient
supine on a radiolucent table with the hip and limb prepared
and draped. Alternatively, the patient can be positioned in
a lateral decubitus position to facilitate management of the
soft tissue.

FIGURE 38: Place 2.0mm wire

Make an incision through the scar created when inserting
the nail. Bluntly dissect down to the greater trochanter.
Place the 2.0mm Guide Insertion Wire, or any 2.0mm K-wire
of adequate length, into the proximal end of the nail. Check
position in both the AP and lateral planes (Figure 38).
If necessary, advance the 9.5mm Cannulated Rigid Reamer
over the guide wire to the nail in order to remove bone or
fibrous tissue over the proximal end of the nail (Figure 39).
WARNING:
Do not allow reamer to contact metal implant.
4

FIGURE 39: If necessary, remove
bone or fibrous tissue

Note: Do not impact Cannulated T-handle driver.

If End Cap is in place, advance the 2.0mm Guide Insertion
Wire through the hole in the End Cap and nail and pass the
Cannulated Screwdriver over the Guide Wire to the End
Cap. Remove after engaging the End Cap (Figure 40).

FIGURE 40: Remove end cap

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Pass the Extraction Adapter over the 2.0mm Guide Insertion
Wire (Figure 41).
1

Note: Ensure that the Extraction Adapter is tight to avoid
fracture of the nail.

Remove all proximal and distal locking screws (Figure 42).
Remove the 2.0mm Guide Insertion Wire (Figure 43).

FIGURE 41: Pass Extraction Adapter

FIGURE 42: Remove locking screws

FIGURE 43: Remove Guide
Insertion Wire
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PediNail™

Attach the Slap Hammer to the Extraction Adapter
(Figure 43).
Gently extract the nail using the Slap Hammer and
Extraction Adapter (Figure 44).
Irrigate the wounds and close in the usual fashion.

FIGURE 43: Attach the Slap
Hammer

FIGURE 44: Gently extract the nail

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PRODUCT INFORMATION

Item Number

Qty

Description

Length (mm)

10-1500-071

1

7mm x 20cm Pediatric Femoral IM Nail

200

10-1500-072

1

7mm x 22cm Pediatric Femoral IM Nail

220

10-1500-073

1

7mm x 24cm Pediatric Femoral IM Nail

240

10-1500-074

1

7mm x 26cm Pediatric Femoral IM Nail

260

10-1500-075

1

7mm x 28cm Pediatric Femoral IM Nail

280

10-1500-076

1

7mm x 30cm Pediatric Femoral IM Nail

300

10-1500-081

1

8mm x 24cm Pediatric Femoral IM Nail

240

10-1500-082

1

8mm x 26cm Pediatric Femoral IM Nail

260

10-1500-083

1

8mm x 28cm Pediatric Femoral IM Nail

280

10-1500-084

1

8mm x 30cm Pediatric Femoral IM Nail

300

10-1500-085

1

8mm x 32cm Pediatric Femoral IM Nail

320

10-1500-086

1

8mm x 34cm Pediatric Femoral IM Nail

340

10-1500-087

1

8mm x 36cm Pediatric Femoral IM Nail

360

10-1500-091

1

9mm x 28cm Pediatric Femoral IM Nail

280

10-1500-092

1

9mm x 30cm Pediatric Femoral IM Nail

300

10-1500-093

1

9mm x 32cm Pediatric Femoral IM Nail

320

10-1500-094

1

9mm x 34cm Pediatric Femoral IM Nail

340

10-1500-095

1

9mm x 36cm Pediatric Femoral IM Nail

360

10-1500-096

1

9mm x 38cm Pediatric Femoral IM Nail

380

01-1500-0307

1

PediNail Implant Base Left

--

01-1500-0308

1

PediNail Implant Tray Left

--

01-1500-0302

1

PediNail Lid

--

PediNail™

LEFT FEMUR IMPLANT

CASE & TRAY

35

35

PediNail™

PRODUCT INFORMATION

LEFT XL FEMUR IMPLANT
Item Number

Qty

Description

Length (mm)

10-1500-077

1

7mm x 32cm Pediatric Femoral IM Nail

320

10-1500-078

1

7mm x 34cm Pediatric Femoral IM Nail

340

10-1500-079

1

7mm x 36cm Pediatric Femoral IM Nail

360

10-1500-080

1

7mm x 38cm Pediatric Femoral IM Nail

380

10-1500-088

1

8mm x 38cm Pediatric Femoral IM Nail

380

10-1500-089

1

8mm x 40cm Pediatric Femoral IM Nail

400

10-1500-090

1

8mm x 42cm Pediatric Femoral IM Nail

420

10-1500-097

1

9mm x 40cm Pediatric Femoral IM Nail

400

10-1500-098

1

9mm x 42cm Pediatric Femoral IM Nail

420

10-1500-101

1

10mm x 30cm Pediatric Femoral IM Nail

300

10-1500-102

1

10mm x 32cm Pediatric Femoral IM Nail

320

10-1500-103

1

10mm x 34cm Pediatric Femoral IM Nail

340

10-1500-104

1

10mm x 36cm Pediatric Femoral IM Nail

360

10-1500-105

1

10mm x 38cm Pediatric Femoral IM Nail

380

10-1500-106

1

10mm x 40cm Pediatric Femoral IM Nail

400

10-1500-107

1

10mm x 42cm Pediatric Femoral IM Nail

420

01-1500-0405

1

PediNail XL Implant Base Left

--

01-1500-0406

1

PediNail XL Implant Tray Left

--

01-1500-0302

1

PediNail Lid

--

CASE & TRAY

36 36

PRODUCT INFORMATION

Item Number

Qty

Description

Length (mm)

10-1500-021

1

7mm x 20cm Pediatric Femoral IM Nail

200

10-1500-022

1

7mm x 22cm Pediatric Femoral IM Nail

220

10-1500-023

1

7mm x 24cm Pediatric Femoral IM Nail

240

10-1500-024

1

7mm x 26cm Pediatric Femoral IM Nail

260

10-1500-025

1

7mm x 28cm Pediatric Femoral IM Nail

280

10-1500-026

1

7mm x 30cm Pediatric Femoral IM Nail

300

10-1500-031

1

8mm x 24cm Pediatric Femoral IM Nail

240

10-1500-032

1

8mm x 26cm Pediatric Femoral IM Nail

260

10-1500-033

1

8mm x 28cm Pediatric Femoral IM Nail

280

10-1500-034

1

8mm x 30cm Pediatric Femoral IM Nail

300

10-1500-035

1

8mm x 32cm Pediatric Femoral IM Nail

320

10-1500-036

1

8mm x 34cm Pediatric Femoral IM Nail

340

10-1500-037

1

8mm x 36cm Pediatric Femoral IM Nail

360

10-1500-041

1

9mm x 28cm Pediatric Femoral IM Nail

280

10-1500-042

1

9mm x 30cm Pediatric Femoral IM Nail

300

10-1500-043

1

9mm x 32cm Pediatric Femoral IM Nail

320

10-1500-044

1

9mm x 34cm Pediatric Femoral IM Nail

340

10-1500-045

1

9mm x 36cm Pediatric Femoral IM Nail

360

10-1500-046

1

9mm x 38cm Pediatric Femoral IM Nail

380

01-1500-0311

1

PediNail Implant Base Right

--

01-1500-0315

1

PediNail Implant Tray Right

--

01-1500-9316

1

PediNail Screw Caddy Lid

--

PediNail™

RIGHT FEMUR IMPLANT

CASE & TRAY

37

37

PediNail™

PRODUCT INFORMATION

RIGHT XL FEMUR IMPLANT
Item Number

Qty

Description

Length (mm)

10-1500-027

1

7mm x 32cm Pediatric Femoral IM Nail

320

10-1500-028

1

7mm x 34cm Pediatric Femoral IM Nail

340

10-1500-029

1

7mm x 36cm Pediatric Femoral IM Nail

360

10-1500-030

1

7mm x 38cm Pediatric Femoral IM Nail

380

10-1500-038

1

8mm x 38cm Pediatric Femoral IM Nail

380

10-1500-039

1

8mm x 40cm Pediatric Femoral IM Nail

400

10-1500-040

1

8mm x 42cm Pediatric Femoral IM Nail

420

10-1500-047

1

9mm x 40cm Pediatric Femoral IM Nail

400

10-1500-048

1

9mm x 42cm Pediatric Femoral IM Nail

420

10-1500-051

1

10mm x 30cm Pediatric Femoral IM Nail

300

10-1500-052

1

10mm x 32cm Pediatric Femoral IM Nail

320

10-1500-053

1

10mm x 34cm Pediatric Femoral IM Nail

340

10-1500-054

1

10mm x 36cm Pediatric Femoral IM Nail

360

10-1500-055

1

10mm x 38cm Pediatric Femoral IM Nail

380

10-1500-056

1

10mm x 40cm Pediatric Femoral IM Nail

400

10-1500-057

1

10mm x 42cm Pediatric Femoral IM Nail

420

01-1500-0407

1

PediNail XL Implant Base Right

--

01-1500-0408

1

PediNail XL Implant Tray Right

--

01-1500-0302

1

PediNail Lid

--

CASE & TRAY

38 38

PRODUCT INFORMATION

Item Number

Qty

Description

Length (mm)

10-1500-000

1

IM Nail End Cap 0mm

--

10-1500-0005

1

IM Nail End Cap 5mm

--

10-1500-0010

1

IM Nail End Cap 10mm

--

10-1500-0015

1

IM Nail End Cap 15mm

--

10-1500-0020

1

IM Nail End Cap 20mm

--

PediNail™

IM NAIL END CAP

4.0mm CORTICAL SCREW
10-1500-2015

2

4.0mm x 15mm Cortical Screw

15

10-1500-2020

2

4.0mm x 20mm Cortical Screw

20

10-1500-2025

2

4.0mm x 25mm Cortical Screw

25

10-1500-2030

2

4.0mm x 30mm Cortical Screw

30

10-1500-2035

2

4.0mm x 35mm Cortical Screw

35

10-1500-2040

2

4.0mm x 40mm Cortical Screw

40

10-1500-2045

2

4.0mm x 45mm Cortical Screw

45

10-1500-2050

2

4.0mm x 50mm Cortical Screw

50

10-1500-2055

2

4.0mm x 55mm Cortical Screw

55

10-1500-2060

2

4.0mm x 60mm Cortical Screw

60

4.5mm CORTICAL SCREW
10-1500-3016

2

4.5mm x 16mm Cortical Screw

16

10-1500-3018

2

4.5mm x 18mm Cortical Screw

18

10-1500-3020

2

4.5mm x 20mm Cortical Screw

20

10-1500-3022

2

4.5mm x 22mm Cortical Screw

22

10-1500-3024

2

4.5mm x 24mm Cortical Screw

24

10-1500-3026

2

4.5mm x 26mm Cortical Screw

26

10-1500-3028

2

4.5mm x 28mm Cortical Screw

28

10-1500-3030

2

4.5mm x 30mm Cortical Screw

30

10-1500-3032

2

4.5mm x 32mm Cortical Screw

32

10-1500-3034

2

4.5mm x 34mm Cortical Screw

34

10-1500-3036

2

4.5mm x 36mm Cortical Screw

36

10-1500-3038

2

4.5mm x 38mm Cortical Screw

38

10-1500-3044

2

4.5mm x 44mm Cortical Screw

44

10-1500-3046

2

4.5mm x 46mm Cortical Screw

46

39

39

PediNail™

PRODUCT INFORMATION

4.5mm CORTICAL SCREW continued
Item Number

Qty

Description

Length (mm)

10-1500-3048

2

4.5mm x 48mm Cortical Screw

48

10-1500-3050

2

4.5mm x 50mm Cortical Screw

50

10-1500-3055

2

4.5mm x 55mm Cortical Screw

55

10-1500-3060

2

4.5mm x 60mm Cortical Screw

60

10-1500-3065

2

4.5mm x 65mm Cortical Screw

65

10-1500-3070

2

4.5mm x 70mm Cortical Screw

70

10-1500-3075

2

4.5mm x 75mm Cortical Screw

75

10-1500-3080

2

4.5mm x 80mm Cortical Screw

80

10-1500-3085

2

4.5mm x 85mm Cortical Screw

85

4.5mm CORTICAL RECON SCREW
10-1500-4045

2

4.5mm x 45mm Cortical Recon Screw

45

10-1500-4050

2

4.5mm x 50mm Cortical Recon Screw

50

10-1500-4055

2

4.5mm x 55mm Cortical Recon Screw

55

10-1500-4060

2

4.5mm x 60mm Cortical Recon Screw

60

10-1500-4065

2

4.5mm x 65mm Cortical Recon Screw

65

10-1500-4070

2

4.5mm x 70mm Cortical Recon Screw

70

10-1500-4075

2

4.5mm x 75mm Cortical Recon Screw

75

10-1500-4080

2

4.5mm x 80mm Cortical Recon Screw

80

10-1500-4085

2

4.5mm x 85mm Cortical Recon Screw

85

10-1500-4090

2

4.5mm x 90mm Cortical Recon Screw

90

10-1500-4095

2

4.5mm x 95mm Cortical Recon Screw

95

10-1500-4100

2

4.5mm x 100mm Cortical Recon Screw

100

1

PediNail Screw Caddy

SCREW CADDY
01-1500-9315

40 40

--

PRODUCT INFORMATION

Item Number

Qty

Description

Length (mm)

01-1500-007

1

7mm Exchange Tube

--

01-1500-010

1

10mm Tissue Protector

--

01-1500-012

1

12mm Tissue Protector

--

01-1500-075

1

7.5mm IM Reamer Head

--

01-1500-080

1

8.0mm IM Reamer Head

--

01-1500-085

1

8.5mm IM Reamer Head

--

01-1500-090

1

9.0mm IM Reamer Head

--

01-1500-095

1

9.5mm IM Reamer Head

--

01-1500-100

1

10.0mm IM Reamer Head

--

01-1500-105

1

10.5mm IM Reamer Head

--

01-1500-110

1

11.0mm IM Reamer Head

--

01-1500-115

1

11.5mm IM Reamer Head

--

01-1500-120

1

12.0mm IM Reamer Head

--

01-1500-008

1

9.5mm Cannulated Entry Reamer

01-1500-060

2

Flexible IM Reamer Shaft

01-1500-0160

1

6.0mm One Piece Flexible Reamer Shaft

01-1500-0165

1

6.5mm One Piece Flexible Reamer Shaft

01-1500-0170

1

7.0mm One Piece Flexible Reamer Shaft

01-1500-021

2

2.9mm Short Drill

01-1500-024

2

3.2mm Short Drill

01-1500-9015

2

3.2mm Calibrated Drill Bit

01-1500-9016

1

4.5mm Calibrated Drill Bit

PediNail™

TISSUE PROTECTORS

REAMER HEADS

REAMER SHAFTS

-----

DRILLS
-----

41

41

PediNail™

PRODUCT INFORMATION

GUIDE WIRES
Item Number

Qty

Description

Length (mm)

11-1500-002

1

2.0mm Guide Insertion Wire

--

11-1500-006

1

2.7mm x 81cm Ball Tipped Reaming Rod

--

GUIDE TUBES
21-1500-9006

2

Outer Guide Tube

--

21-1500-9007

2

4.5mm Guide Tube

--

21-1500-9008

2

3.2mm Guide Tube

--

HEX DRIVERS

42 42

01-1500-9017

1

3.5mm Hex Driver Long Shaft

--

01-1500-9019

1

Ball Hex Driver

--

01-1500-9020

1

3.5mm Hex Driver Short Shaft

--

01-1500-026

1

T-Handle Hex Driver for Targeting Device

--

PRODUCT INFORMATION

Item Number

Qty

Description

Length (mm)

11-1500-001

2

3.2mm Threaded Tipped Guide Wire

--

01-1500-008

1

9.5mm Entry Reamer

--

01-1500-014

1

Nail Measuring Gauge

--

01-1500-034

1

Mini Q/C Chuck

--

01-1500-035

1

Depth Gauge Long (10-100mm)

--

01-1500-036

1

T-Handle Wire Inserter

--

01-1500-9011

1

IM Reducer

--

01-1500-9014

1

Trocar

--

01-1030-001

1

AO Q/C Handle

--

11-1500-005

1

Exchange Tube

--

01-1500-018

1

Slotted Mallet

--

01-1500-9012

1

Impaction Rod

--

01-1500-9013

1

Slap Hammer

--

01-1500-9018

1

Extraction Adapter

--

01-1500-9000

1

Modular Targeting Device

--

21-1500-9005

1

Targeting Device Attachment Bolt

--

01-1500-9304

1

PediNail Instrument #1 Base

--

01-1500-9305

1

PediNail Instrument #1 Tray

--

01-1500-9301

1

PediNail Instrument #2 Base

--

01-1500-9302

1

PediNail Lid

--

PediNail™

MISCELLANEOUS INSTRUMENTS

43

43

PediNail™
CAUTION: Federal law restricts this device to sale by or
the order of a Physician.

This document is intended exclusively for experts in the field, i.e. physicians in
particular, and expressly not for the information of laypersons.

CAUTION: Devices are supplied Non-Sterile. Clean and
sterilize before use according to instructions.

The information on the products and/or procedures contained in this document
in of general nature and does not represent medical advice or recommendations.
Since this information does not constitute any diagnostic or therapeutic statement
with regard to any individual medical case, individual examination and advising
of the respective patient are absolutely necessary and are not replaced by this
document in whole or in part.

CAUTION: Implants components are single-use. Do not
reuse.
CAUTION: The device is not approved for screw
attachment or fixation to the posterior
elements (pedicles) of the cervical,
thoracic or lumbar spine
CAUTION: Only those instruments and implants contained
within this system are recommended for
use with this technique. Other instruments
or implants used in combination or in place
of those contained within this system is not
recommended.
This technique has been provided by one of our
medical advisors only as guidance and it is not
intended to limit the methods used by trained
and experienced surgeons.

The information contained in this document was gathered and compiled by
medical experts and qualified OrthoPediatrics employees to the best of their
knowledge. The greatest care was taken to ensure the accuracy and ease
of the understanding of the information used and presented.
OrthoPediatrics does not assume any liability, however, for the timeliness,
accuracy, completeness or quality of the information and excludes any liability for
tangible or intangible losses that may be caused by the use of this information.

Instructions For Use (IFU), cleaning instructions, and surgical
techniques may be obtained by calling OrthoPediatrics® Customer
Service at 574-268-6379. Read and understand indications, warnings,
and adverse effects explained in IFU's prior to use.
OrthoPediatrics, Children Are Not Just Small Adults, ArmorLink, PediFlex,
PediFrag, PediLoc, PediNail, PediPlates, PLEO, Response, Scwire, ShieldLoc,
and the OP and Pedi logos are trademarks of OrthoPediatrics Corp.
OrthoPediatrics, Children Are Not Just Small Adults, PediPlates, PediLoc,
Scwire and the Pedi logo are registered trademarks in the United States. The
Pedi logo is a registered trademark in Australia and New Zealand, and a
registered Community Trade Mark.

44 44

OrthoPediatrics Corp. ©2015 ST-1500-01-01

2850 Frontier Drive • Warsaw, IN 46582 • ph: 574.268.6379 or 877.268.6339 • fax: 574.268.6302 • www.OrthoPediatrics.com



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