to facilitate the insertion of im nails flexible reamers ...synthes.vo.llnwd.net/o16/llnwmb8/us...

To Facilitate the Insertion of IM Nails

Flexible Reamers for Intramedullary NailsSurgical Technique

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Flexible Reamers for Intramedullary Nails Surgical Technique DePuy Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Flexible Reamers for Intramedullary Nails 2

Reduction 7

Confirm Nail Length 9

Medullary Reaming 11

Cleaning Flexible Shaft 14

Instruments 15

Set List 18

Intended UseThe Monobloc or Modular Intramedullary Flexible Reamers are intended to ream an intramedullary bone canal in preparation for insertion of implants (e.g. intramedullary nails or stems).

2 DePuy Synthes Flexible Reamers for Intramedullary Nails Surgical Technique

Flexible Reamers for Intramedullary Nails

Modular Intramedullary Flexible Reaming SystemThe thin flexible shaft and deeply fluted reamer heads are designed to help reduce intramedullary pressure and increase flow of bone chips and marrow during reaming.1

• Single shaft to drive all reamer heads• Reamer heads are coupled to the shaft without

hand contact with the reamer head• Ball of 2.5 mm reaming rod will fit through the

cannulation of all DePuy Synthes nail connecting screws

1. C. A. Muller, R. Schavan, R. Frigg, S. M. Perren. “Intramedullary pressure increase for different commercial and experimental reaming systems: an experimental investigation.” Journal of Orthopedic Trauma. 12 (1998): 540–546.

*Also available.

5.0 mm Flexible ShaftAvailable in 470 mm and 620 mm* lengths• 5.0 mm shaft is made of Nitinol, a nickel-titanium alloy

with superelastic properties• Single shaft for all reamer sizes• Can be driven forward or reverse• Couples with reduction drive• Cannulated



2.5 mm Reaming Rod with ball tipAvailable sterile in 650 mm,* 950 mm,* 1150 mm,* and 950 mm and 1150 mm with an extension*• Secures connection between the reamer head and the

flexible shaft• Helps to guide the flexible shaft past the reduced fracture

Precaution: Never ream without using a reaming rod, as it secures the connection between the reamer head and the flexible shaft.

351.706S/351.708S/351.709S

351.707S/351.704S

*Also available.

Medullary Reamer Heads• Sizes from 8.5 mm to 19.0 mm, in 0.5 mm increments• The 8.5 mm reamer head is front-cutting, all others are

side-cutting• The 8.5 mm reamer head should only be used in a

medullary canal with an isthmus 8.0 mm or larger. If necessary, use the hand reamers or Monobloc Flexible Reamers to open the canal to 8.0 mm first

• To reduce the likelihood of the reamer head jamming intraoperatively, do not skip reamer head sizes

Notes: • Inspect the reamer heads for damages, as blunt

reamer heads can increase intramedullary pressure and tempera ture significantly.2–3

• For technical reasons (cutting geometry), the reamer heads cannot be resharpened. Damaged reamer heads have to be replaced.

Precaution: Never ream without using a reaming rod, as it secures the connection between the reamer head and the flexible shaft.

Good Reaming Practices• Inspect reamer heads for dullness before every

surgery that requires reaming• Ream with a ball tipped reaming rod• Widen canals narrower than 8.0 mm with the

hand reamers or Monobloc Flexible Reamers• Ream in 0.5 mm increments; do not skip reamer

head sizes

2. Muller C.A., Mc Iff T., Rahn B.A., Pfister U., Weller S.: Intramedullary pressure, strain on the diaphysis and increase in cortical temperature when reaming the femoral medullary cavity–A comparison of blunt and sharp reamers. Injury 24, Suppl. 3: 22–30

3. Muller C.A., Rahn B.A., Pfister U., Weller S.: Extent of bluntness and damage to reamers from hospitals. Injury 24, Suppl. 3, 31–35


Hand Reamers, 6.0 mm, 7.0 mm, 8.0 mm• For use in medullary canals with an isthmus smaller

than 8.0 mm • Use hand reamers incrementally to widen the medullary

canal to 8.0 mm, before using the front-cutting 8.5 mm medullary reamer head under power

• In sclerotic medullary canals, the hand reamers may be used before insertion of the reaming rod

• 450 mm length


*Also available.

Monobloc Flexible Reamers*• From sizes 6.0 mm to 10.5 mm in 0.5 mm increments• 385 mm length• Flexible laser pattern, one piece, front-cutting reamers• Couples with Modified Trinkle drill couplings or Jacobs

Chuck drill couplings



Depth Gauge and Depth Gauge Extension Tube• Used to determine nail length and estimate canal size• The depth gauge is used with the 650 mm reaming rod• The depth gauge and extension tube are used with the

950 mm and 1150 mm length reaming rods

351.717

351.719

Holding Forceps• Used to insert and maintain placement of the reaming

rod in the medullary canal

7.0 mm Reduction Heads, straight or angled• Attach to the flexible shaft• Help reduce fractures and aid in passage of the

reaming rod• Must be used with the 2.5 mm reaming rod



1. Insertion

Handling Technique for Reaming Rod and Medullary Reamers

2. HoldingDuring reaming, grasp the end of the reaming rod to prevent its withdrawal. After the reamer head is removed from the canal, grasp the reaming rod between the reamer head and the canal entry point.

3. Emergency applicationIf a reamer head jams, use the holding forceps for reaming rods to grasp the back end of the reaming rod, and remove the jammed reamer with light hammer blows on the holding forceps.


Reduction

1. Reduce fracture

Instruments

351.15 Flexible Shaft Handle

352.040 5.0 mm Flexible Shaft, 470 mm

7.0 mm Reduction Heads 352.050 straight 352.055 angled

2.5 mm Reaming Rods with ball tip, sterile* 351.709S 650 mm, with extension 351.706S 950 mm 351.707S 950 mm, with extension 351.708S 1150 mm 351.704S 1150 mm, with extension

*Also available.


Reduction

A

C

Assemble one of the reduction heads onto the 5.0 mm flexible shaft (A).

Attach the shaft to the flexible shaft handle (B).

Insert the smooth end of a 2.5 mm reaming rod (C) into the tip of the 7.0 mm reduction head until the ball tip touches the reduction head (D).

Insert the reduction system into the medullary cavity and reduce the fragments under imaging.

Precaution: A secure fixation of the reduction head is not guaranteed if the reduction system is used without the reaming rod. The reduction head may be lost in the medul lary canal.

After reduction has been achieved, remove the reduction assembly and leave the reaming rod in the canal. Advance the reaming rod to the desired depth of implant.

Precaution: As each manipulation in the fat-filled medullary cavity causes an intramedullary pressure increase, reduction with the reduction system also increases the pressure. Ma nipulations should therefore be minimized. As an alternative, reduction can also be carried out using the reaming rod only.

D

B


Confirm Nail Length

2. Confirm nail length and estimate canal size

Instruments

351.717 Depth Gauge

351.719 Depth Gauge Extension Tube

Assemble the depth gauge extension tube to the depth gauge.

Note: To measure the nail length when the 650 mm reaming rod is used, the extension tube is not required.

show reaming rod continuing down canal new image to come


Confirm Nail Length

Place the depth gauge assembly over the 2.5 mm reaming rod. The tip of the extension tube, or the depth gauge, should be positioned at the desired location of the proximal end of the implant.

650 mm and 950 mm reaming rodsRead the nail length at the end of the reaming rod on the scale of the depth gauge.

1150 mm reaming rodRead the nail length at the mark on the reaming rod.

Use the depth gauge to estimate the size of the medullary canal. Place the depth gauge across the limb at the level of the isthmus. Move the depth gauge until the tab fills the canal.

Precaution: The distance of the depth gauge from the bone and the position of the receiver affect the diameter measurement. Always place the depth gauge on the side of the limb closest to the receiver. Estimate the width as follows: Distance between depth gauge and bone a. 25 mm = 1 mm larger reading b. 50 mm = 2 mm larger reading c. 100 mm = 3 mm larger reading


Medullary Reaming

511.785

3. Ream medullary canal

Instruments

351.05 Tissue Protector

2.5 mm Reaming Rods with ball tip, sterile* 351.709S 650 mm 351.706S 950 mm 351.707S 950 mm, with extension 351.708S 1150 mm 351.704S 1150 mm, with extension

351.782 Holding Forceps

351.783 Removal Instrument

Hand Reamers 351.92 6.0 mm Hand Reamer 351.93 7.0 mm Hand Reamer 351.94 8.0 mm Hand Reamer

5.0 mm Flexible Shafts 352.040 470 mm 352.044* 620 mm

352.085 8.5 mm Medullary Reamer Heads

Monobloc Flexible Reamers 03.028.060* 6.0 mm 03.028.065* 6.5 mm 03.028.070* 7.0 mm 03.028.075* 7.5 mm 03.028.080* 8.0 mm

511.785** Reduction Drive Unit

511.701** ComPact Air Drive II

05.001.210** AO Reaming Attachment

05.001.201** Trauma Recon System Handpiece

*Also available.**Not available in Flexible Reamers for Intramedullary Nailing Instrument set.


Medullary Reaming

In medullary canals with an isthmus narrower than 8.0 mm, or in sclerotic medullary canals, use the hand reamer(s) or the Monobloc Flexible Reamers over the 2.5 mm reaming rod to widen the canal to 8.0 mm before using the power driven, front-cutting 8.5 mm reamer head.

Precaution: Monobloc Flexible Reamers must be used with drill power configurations only. DO NOT use reaming power configurations as it will cause reamer breakage in the event that the reamer is incarcerated.

Clip the shaft onto the reamer head in the tray. If necessary, rotate the shaft slightly until the connection fits.

For the initial reaming, the flexible shaft is usually equipped with the 8.5 mm reamer head. Clip the shaft onto the reamer head in the Tray for Reaming Heads. If the click-on connection does not fit, turn the shaft slightly until the hexagon matches.

Precaution: This is only a primary connection. Always ream over the reaming rod to ensure a secure connection.

Use the ComPact Air Drive II with the reduction drive unit or the Trauma Recon System with the AO reaming attachment (as the driving unit). Guide the reaming system over the reaming rod.

Do not rotate the reamer head when inserting it into the medullary canal. The tissue protector protects the soft tissues. Use the highest speed and slight but uniform force to advance the reamer head in the medullary canal. Move the reaming shaft back and forth to remove bone chips from the reamer head, and prevent jamming of the reamer head.

After reaming, withdraw the reaming shaft until the entire reamer head is visible. To prevent a loss of reduction, grasp the reaming rod at the canal entry point and hold the rod in place using the holding forceps.


Medullary Reaming

If a reamer jams while reaming, disconnect the reduction drive unit. Use the holding forceps to grasp the reaming rod (in the countersinking). Use light hammer blows on the holding forceps to withdraw the jammed reamer head from the medullary canal. As an alternative, release the reamer head by rotating the shaft in reverse.

The reamer head can be removed from the flexible shaft with the removal tool. Place the reamer head in the slot on the side of the removal tool. Hold the removal tool with one hand while pulling on the flexible shaft with the other. The reamer head will detach from the shaft.

Use the sideways cutting reamer heads for the subsequent reaming steps. Reaming should always be performed in 0.5 mm increments.

Leave the 2.5 mm reaming rod in position for insertion of the cannulated nail.

Note: The 2.5 mm ball tip reaming rod can be passed through the cannulation of all DePuy Synthes titanium nails and their respective instruments. When used with other nailing systems, the cannulation of the nail connecting screw must be larger than 3.5 mm.

Precaution: The reamer head can only be disengaged from the shaft if the reaming rod has been removed.


Cleaning Flexible Shaft

Cleaning flexible shaft

Instrument

3.6 mm Cleaning Brush 352.041** 680 mm 352.045* 830 mm

Use cleaning brush to clean the cannulation of the flexible shaft. In case of an obstructed cannulation, use the reaming rod to push through it. The cleaning brush cannot be autoclaved.

Precaution: The Cleaning Brush is intended for cleaning purposes only and may not be brought into the sterile field in the operating theater.

Note: The Monobloc Flexible Reamers and the associated graphic case (60.028.000 and 60.028.001) follow different cleaning guidelines than the standard DePuy Synthes cleaning guidelines. For cleaning instructions for the Monobloc Flexible Reamers and associated graphic case part numbers 03.028.060–03.028.105 and 60.028.000–60.028.001, refer to www.avalign.com/ifu; packaging insert # RD_IFU-0001.

*Also available.**Not included in set.

http://www.avalign.com/ifu


351.05 Tissue Protector

351.15 Flexible Shaft Handle

351.717 Depth Gauge

2.5 mm Reaming Rods with ball tip, sterile* 351.709S 650 mm 351.706S 950 mm 351.708S 1150 mm

351.719 Depth Gauge Extension Tube

Instruments

*Also available.

2.5 mm Reaming Rods with ball tip and extension, sterile* 351.707S 950 mm 351.704S 1150 mm


Instruments

351.782 Holding Forceps

352.055 7.0 mm Reduction Head, angled

352.040 5.0 mm Flexible Shaft, 470 mm 352.044* 5.0 mm Flexible Shaft, 620 mm

352.050 7.0 mm Reduction Head, straight

351.92 6.0 mm Hand Reamer 351.93 7.0 mm Hand Reamer 351.94 8.0 mm Hand Reamer

351.783 Removal Tool

352.041* 3.6 mm Cleaning Brush, 680 mm 352.045* 3.6 mm Cleaning Brush, 830 mm

*Also available.


393.10 Universal Chuck with T-Handle

Monobloc Flexible Reamers, 385 mm03.028.060* 6.0 mm 03.028.065* 6.5 mm 03.028.070* 7.0 mm 03.028.075* 7.5 mm 03.028.080* 8.0 mm 03.028.085* 8.5 mm 03.028.090* 9.0 mm03.028.095* 9.5 mm03.028.100* 10.0 mm03.028.105* 10.5 mm

Instruments

*Also available.

355.006 Medullary Tube

Note: Single sterilization only. Do not use with 3.0 mm Reaming Rod with offset ball tip (351.71)

352.085– Medullary Reamer Heads, 8.5 mm to 352.190 19.0 mm (0.5 mm increments)


Flexible Reamer Set for IM Nails (150.060)

Graphic Case690.382 Flexible Reamers for Intramedullary Nails Instrument Set Graphic Case

Instruments351.05 Tissue Protector351.15 Flexible Shaft Handle, quick coupling,

cannulated351.717 Depth Gauge351.719 Depth Gauge Extension Tube351.782 Holding Forceps351.783 Removal Tool, for use with Medullary

Reaming Heads351.92 6.0 mm Hand Reamer351.93 7.0 mm Hand Reamer351.94 8.0 mm Hand Reamer352.040 5.0 mm Flexible Shaft, 470 mm, 2 ea.352.050 7.0 mm Reduction Head, straight352.055 7.0 mm Reduction Head, angled393.10 Universal Chuck with T-Handle

Monobloc Flexible Reamers, 385 mm03.028.060 6.0 mm 03.028.065 6.5 mm 03.028.070 7.0 mm 03.028.075 7.5 mm 03.028.080 8.0 mm

Medullary Reamer Heads Dia. (mm) Dia. (mm)

352.085 8.5 352.140 14.0

352.090 9.0 352.145 14.5

352.095 9.5 352.150 15.0

352.100 10.0 352.155 15.5

352.105 10.5 352.160 16.0

352.110 11.0 352.165 16.5

352.115 11.5 352.170 17.0

352.120 12.0 352.175 17.5

352.125 12.5 352.180 18.0

352.130 13.0 352.185 18.5

352.135 13.5 352.190 19.0

Note: For additional information, please refer to package insert.

For detailed cleaning and sterilizationinstructions, please refer towww.depuysynthes.com/hcp/cleaning-sterilization or sterilization instructions, if provided.

Note: The Monobloc Flexible Reamers and the associated graphic case (60.028.000 and 60.028.001) follow different cleaning guidelines than the standardDePuy Synthes cleaning guidelines. For cleaninginstructions for the Monobloc Flexible Reamers and associated graphic case part numbers 03.028.060–03.028.105 and 60.028.000–60.028.001, refer to www.avalign.com/ifu; packaging insert # RD_IFU-0001.

www.depuysynthes.com/hcp/cleaning-sterilization

http://www.avalign.com/ifu


Flexible Reamer Set, Long (01.004.306)

Graphic Case60.004.306 Flexible Reamer Set Graphic Case, long

Instruments351.05 Tissue Protector351.15 Flexible Shaft Handle, quick coupling,

cannulated351.717 Depth Gauge351.719 Depth Gauge Extension Tube351.782 Holding Forceps351.783 Removal Tool, for use with Medullary

Reaming Heads352.044 5.0 mm Flexible Shaft, 620 mm, 2 ea.352.050 7.0 mm Reduction Head, straight352.055 7.0 mm Reduction Head, angled393.105 Small Universal Chuck with T-Handle

Medullary Reamer Heads Dia. (mm) Dia. (mm)

352.085 8.5 352.140 14.0

352.090 9.0 352.145 14.5

352.095 9.5 352.150 15.0

352.100 10.0 352.155 15.5

352.105 10.5 352.160 16.0

352.110 11.0 352.165 16.5

352.115 11.5 352.170 17.0

352.120 12.0 352.175 17.5

352.125 12.5 352.180 18.0

352.130 13.0 352.185 18.5

352.135 13.5 352.190 19.0


Also Available

Instruments 351.16J Flexible Shaft Connector for Jacobs

chuck, quick coupling, cannulated

351.704S 2.5 mm Reaming Rod with ball tip and extension, 1150 mm, sterile

351.706S 2.5 mm Reaming Rod with ball tip, 950 mm, sterile

351.707S 2.5 mm Reaming Rod with ball tip and extension, 950 mm, sterile



352.041 3.6 mm Cleaning Brush, 680 mm352.044 5.0 mm Flexible Shaft, 620 mm

352.045 3.6 mm Cleaning Brush, 830 mm

355.006 Medullary Tube

511.761 Large Quick Coupling

511.785 Reduction Drive Unit

Monobloc Flexible Reamers, 385 mm

03.028.060 6.0 mm

03.028.065 6.5 mm

03.028.070 7.0 mm

03.028.075 7.5 mm

03.028.080 8.0 mm

03.028.085 8.5 mm

03.028.090 9.0 mm

03.028.095 9.5 mm

03.028.100 10.0 mm

03.028.105 10.5 mm

60.028.000 Base–Monobloc Flexible Reamer Case

60.028.001 Lid–Monobloc Flexible Reamer Case

Recommended Additional SystemsComPact Air Drive II System

Trauma Recon System

Also Available for the Flexible Reamer Set, Long, for IM Nails (01.004.306)351.16J Flexible Shaft Connector for use with Ja-

cobs Chuck

352.040 5.0 mm Flexible Shaft, 470 mm

360.240 IM Nail Reduction Tool, 7.5 mm shaft with curved tip

360.243 Handle for 12.0 mm Tapered Intramedullary Reduction Tool

03.010.093 Reaming Rod Push Rod with Ball Handle

03.010.427 Curved Awl 8 mm Intramedullary Reduction Tool

© DePuy Synthes 2017. All rights reserved.DSUS/TRM/0417/1431(1) 11/17 DV

Synthes USA, LLC 1101 Synthes AvenueMonument, CO 80132

Distributed by:Synthes USA Products, LLC 1302 Wrights Lane EastWest Chester, PA 19380

To order (USA): 800-523-0322 To order (Canada): 855-946-8999

Note: For recognized manufacturer, refer to the product label.

www.depuysynthes.com

Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information.

CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.

Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.

Not all products may currently be available in all markets.

Manufactured by: Avalign Technologies8727 Clinton Park DriveFort Wayne, IN, 46825www.avalign.com

to facilitate the insertion of im nails flexible reamers ...synthes.vo.llnwd.net/o16/llnwmb8/us...

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