Surgical Technique Guide - Shukla Medical

Surgical Technique Guide

...Because Every Minute Counts®

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Xtract-All® Nail (MSK1017) Winquist III Universal IM Nail Extraction System

Contents

Extraction Instruments; pg 4

Introduction ........................................................................................................................................................................ 3

List of Components .......................................................................................................................................................... 4-9 Case #1 ........................................................................................................................................................................................ 5

Case #2 • Level 1 ..................................................................................................................................................................... 6

Case #2 • Level 2 ..................................................................................................................................................................... 7

Surgical Technique ........................................................................................................................................................... 8-10 Methods of Extraction ......................................................................................................................................................... 9

Extractor Compatibility Matrix ..................................................................................................................................... 11

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Introduction Warning and Precautions

Intended Use

The Xtract-All® Nail (MKS1017) Winquist III Universal IM Nail Extraction System is designed to remove virtually any intramedullary nail implant system.

Use together with the Xtract-All® Maxi system (S9MAXI) for lateral IM nail screw removal.

Indications for Use

The Xtract-All® Nail system is intended for use by, or as directed by, a surgeon in any IM nail removal procedure. Includes 17 sizes of threaded extractors to connect to the threaded proximal end of IM nails. Also includes conical, solid, and hook extractors for IM nail removal when nail threads cannot be matched, are missing, or have been damaged.

Preoperative

• Clear x-rays and surgical notes may be used to identify manufacturer, brand, location, & condition of implanted hardware. Use X-Ray Search Engine™ for the most updated information on hardware (see pg 10 for more).

• The surgeon should be familiar with general principles of revision surgery and techniques for removal of implants.

• The instruments should be inspected for visible wear and tear prior to use. Do not use the product if damage is suspected.

• Only validated cleaning and sterilization procedures should be used.

Operative

• Proper handling and storage of the instrumentation is mandatory. Long-term use of this system may produce stresses and cause weakness, which could become a focal point for failure.

• The surgeon should be cautious with limb position change and/or excessive force exertion while extracting implants using the instrumentation provided in the tray.

For detailed sterilization instructions, please refer to industry standards ANSI/AAMI ST79:2012 & A1:2012 and ANSI/AAMI ST8:2001.

NOTE: All Shukla Medical surgical instruments require manual cleaning with a neutral pH cleanser. Open and disassemble all instruments, making sure to remove all contamination during cleaning. Instruments must be reassembled prior to sterilization. Machine washing is not recommended. Maintenance and care using an autoclaveable lubricant on movable parts is required to preserve the life of the instrument. For more cleaning, inspection, maintenance, and care tips, contact Shukla Medical directly.

For detailed cleaning and sterilization instructions, please visit www.ShuklaMedical.com/Sterilization

Cleaning and Sterilization

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Xtract-All® Nail (MKS1017) Winquist III Universal IM Nail Extraction System

Emergo EuropePrinsessegracht 202514 AP The HagueThe Netherlands

EC REP MKS1017REF NON-STERILE PRODUCTNON

STERILE

Shukla Medical8300 Sheen DriveSt. Petersburg, FL 33709USA

CONSULT INSTRUCTIONS FOR USE

i

*Extractor tips (WIN1 through WIN17) are single-use only and must be discarded after use

Part Number Description Qty

CA133 Case #1 1

CA134 Lid #1 1

CA135 Case #2 1

CA136 Lid #2 1

TR001 Tray 1

MIWC Bone Chisel 1

MIWD T-Handle 1

MIWE C-Frame 1

MIWN C-Frame Locking Nut 1

MIWW 1/2” & 11/16” Double Open End Wrench 1

MIWWA 9/32” & 11/16” Double Open End Wrench 1

MMM5 Mallet 1

MDS030020 2.0mm Reverse Capture Hex Driver 1





MDS031562 5/32” Reverse Capture Hex Driver 1

MDS031875 3/16” Reverse Capture Hex Driver 1

MDS060080 T8 Reverse Capture Hex Driver 1




MDS07 #2 Pozidriv 1

MDS08 Cruciform Driver 1

MDS09 Flat Tip Driver 1

MDE19250 1/4”sq. Adapter 1

MDA010006 6mm Standard Hex Tip 2

MDA011006 6mm Female Hex Tip 1

MDA010008 8mm Standard Hex Tip 1

Part Number Description Qty

HD233-M01 Ratcheting T-Handle 1

MHRS0311 Cannulated Ratcheting In-Line Handle 1

WIN1 1/4”-20 Female Extractor Tip 3

WIN2 M6 x 1mm Male Extractor Tip 3

WIN3 1/4”-20 Male Extractor Tip 3


WIN5 M8 x 1.25mm Male Extractor Tip 3








WIN13 M5.5 x 0.9mm Male Extractor Tip 3


WIN15 #8-32 Female Extractor Tip 3

WIN16 M8 x 1mm Male Extractor Tip 3

WIN17 3/8”-32 Female Extractor Tip 3

WIN18 Socket Wrench for Extractor Tips 1

WIN19 Extractor Body 1

WIN20 Solid Nail Extractor 12.5mm-15mm 1

WIN21 Solid Nail Extractor 10mm-12.5mm 1

WIN22 Solid Nail Extractor 8mm-10mm 1

WIN23 Solid Nail Extractor 6mm-8mm 1

WIN24 6” Extension 1

WIN25 Large Hook Adapter 1

WIN26 Small Hook Adapter 1

WIN27 Conical Extractor 1

MKS1017 Xtract-All® Nail Winquist III Universal IM Nail Extraction System

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MKS1017 Case #1

List of Components: Case #1

MKS1017 Case #1

CA133 Case 1: Body

CA134 Case 1: Lid

MIWE C-Frame

MMM5 Mallet

MIWN C-Frame Locking Nut

MIWD T-Handle

MIWC Bone Chisel

MIWWA 9/32” & 11/16” Double Open End Wrench

MIWW 1/2” & 11/16” Double Open End Wrench

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Single-Use Only Extractors


MKS1017 Case #2

CA135 Case 2: Body

CA136 Case 2: Lid

TR001 Case 2: Tray

MKS1017 Case #2 Level #1

WIN18 Socket Wrench for Extractor Tips

WIN19 Extractor Body

WIN20 Solid Nail Extractor 12.5mm-15mm

WIN21 Solid Nail Extractor 10mm-12.5mm

WIN22 Solid Nail Extractor 8mm-10mm

WIN23 Solid Nail Extractor 6mm-8mm

WIN25 Large Hook Adapter

WIN26 Small Hook Adapter

WIN27 Conical Extractor

WIN11/4”-20 Female Extractor

WIN2M6 x 1mm Male Extractor Tip

WIN31/4”-20 Male Extractor Tip


WIN5M8 x 1.25mm Male Extractor Tip








WIN13M5.5 x 0.9mm Male Extractor Tip


WIN15#8-32 Female Extractor Tip

WIN16M8 x 1mm Male Extractor Tip

WIN173/8”-32 Female Extractor Tip

WIN24 6” Extension

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MDS030020 2.0mm Reverse Capture Hex Driver

HD233-M01 Ratcheting T-Handle

MHRS0311 Cannulated Ratcheting In-Line Handle

MKS1017 Case #2 Level #2

MDE19250 1/4”sq. Adapter

MDS09 Flat Tip Driver

MDS08 Cruciform Driver

MDS07 #2 Pozidriv

MDS060250 T25 Reverse Capture Hex Driver




MDS031875 3/16” Reverse Capture Hex Driver

MDS031562 5/32” Reverse Capture Hex Driver





MDA010008 8mm Standard Hex Tip

MDA011006 6mm Female Hex Tip

MDA010006 6mm Standard Hex Tip

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Surgical Technique

1 Remove Bone Screws1. Determine size of bone screw & select appropriate

screwdriver shaft.

2. Insert screwdriver shaft into ratcheting handle & set ratchet to counter-clockwise motion. (Fig. A)

3. Remove all proximal & distal screws.

Figure A

Prepare Nail for Extraction1. Remove excess bone around proximal neck of IM nail

with Bone Chisel (MIWC). (Fig. B)

2. Remove threaded cap if present.

2

Figure B

Figure C

Extraction Method SelectionThe Winquist III system contains several options (Option A-D; Fig. C) to remove IM nail systems in the event that primary or subsequent methods fail.

Note: Extraction methods are presented in the recommended order of execution. Some methods are destructive, causing damage to the nail threads that makes it difficult to return to preceding methods.

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Figure E

Option A: Threaded Extractor Tips (Single-Use)WIN1-WIN19

1. Select compatible extraction tip by matching threads on IM nail to an extractor tip (WIN1 through WIN17). (Fig. D)

2. Tighten the tip into the extractor body (WIN19) using the 9/32” & 11/16” wrenches (MIWWA and MIWW). (Fig. E)

Figure D

Option B: Conical ExtractorWIN27

If a compatible tip cannot be identified, or nail threads are damaged, use the Conical Extractor (Fig. F).

1. Clear excess bone around proximal end of IM nail using the Bone Chisel (MIWC).

2. Drive extractor clockwise into IM nail with downward force, inserting as far as possible and engaging at least 3-4 threads. Extractor will cross-thread IM nail shaft threads, ensuring secure attachment.

Note: Once you use the conical extractor, threaded extraction tips can no longer be used due to thread deformation.

Figure F

Option C: Solid IM Nail ExtractorWIN20-WIN23

If the IM nail interior shaft is inaccessible due to bone growth, or if the IM nail has no opening, use a Solid IM Nail Extractor (Fig. G).

1. Clear excess bone around proximal end of IM nail using the Bone Chisel (MIWC).

2. Choose an extractor large enough to fit completely over the exterior of the IM nail shaft.

3. Drive extractor as far as possible onto IM nail with downward force. The extractor threads will bite into the nail shaft, creating a secure attachment.

Figure G

Option D: Hook ExtractorWIN25-WIN26

If the IM nail cannot be removed using Options A, B, or C, and if a slot, hole, or recess is present, a Hook Extractor may be used (Fig. H).

1. Clear excess bone around proximal end of IM nail using the Bone Chisel (MIWC) so that the hook can fully access the IM nail slot.

2. Engage Hook Extractor with the IM nail.

Figure H

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Extract ImplantExtract implant with repeated strikes of the Mallet (MMM5) on Extraction C-frame strike plate. (Fig. M) If implant resists removal after several strikes, use the Bone Chisel (MIWC) to loosen bone around implant before continuing.

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If extractor tip breaks, (Fig. N) use Socket Wrench (WIN18) to remove broken tip from IM nail. Replace with a new tip and make another attempt.

A Note on Breakage

4 Build Extractor Assembly1. Connect T-handle (MIWD) securely to selected

extractor. Screw extractor into IM nail. (Fig. I)

2. Once extractor is securely attached to IM nail, remove the t-handle, applying counter-torque with the 1/2” Wrench (MIWW) (Fig. J).

3. Connect Extraction C-frame (MIWE) to extractor using a Hex Nut (MIWN). (Fig. K) Tighten nut fully with the 11/16” Wrench (MIWWA), applying counter-torque with the 1/2” Wrench (MIWW).

Figure M

Figure N

Figure L

Implant Removal Tip Compatibility MatrixThe table to the right shows compatibility between a wide range of proprietary implant systems and corresponding Xtract-All® Spine removal tips. This information is updated frequently, as our engineering team continually adds to our range of available tips to cover the continually expanding spinal implant market.

-RAYSearch Engine

-RAYSearch Engine

For the most up-to-date information on supported systems, contact customer service or your local rep for access to our X-Ray Search Engine™ Implant Compatibility Database.

Surgical Technique Continued

Figure I

Figure K

Figure J

Note: If extractor is not long enough to attach to C-frame, use 6” Extension (WIN24 or MIWA22). (Fig. L)

MFR Brand ExtractorWinquist III

Tip #Single

UseDriver Adapter

Acumed® Polarus® Humeral 1/4”-20 UNC-2A WIN3 ✓ 2.5mm† Hex & 3.5mm† Hex

Depuy/Ace® AIM® Humeral 1/4”-20 UNC-2A WIN3 ✓ 2.5mm† Hex & 3.5mm† Hex

AIM® Tibial 1/4”-20 UNC-2A WIN3 ✓ 3.5mm† Hex

AIM® Femoral, Supracondylar & A.R.T.® Retrograde

5/16”-18 UNC-2A WIN6 ✓ 3.5mm† Hex & 5.0mm† Hex

Chandler Tibial 1/4”-28 UNF-2A WIN4 ✓ Not Applicable

Versanail™ Ankle Fusion Nail 5/16”-18 UNC-2A WIN6 ✓ 3.5mm† Hex

smith&nephew® Russel-Taylor® Humeral 7/16”-20 UNF-2A WIN11 ✓ 3/16”† Hex

Russel-Taylor® Femoral & Recon 3/8”-24 UNF-2A WIN10 ✓ 3/16”† Hex & 5/32”† Hex

Russel-Taylor® Tibial 5/16”-24 UNF-2A WIN7 ✓ 5/32”† Hex

Trigen® All 5/16”-24 UNF-2A WIN7 ✓ 6mm Hex Socket & 1/4”sq.

Ender Nail Small hook WIN26 (MIWA14‡) Not applicable

Synthes® Solid Humeral M5.5x0.9 6g WIN13 ✓ 2.5mm† Hex

Solid Tibial M6x1.0 6g WIN2 ✓ 2.5mm† Hex

Solid Femoral, Recon, & Supracondylar M8x1.25 6g/M7x1.0 6g WIN5 ✓ 2.5mm† Hex

Universal Tibial & Femorial Conical WIN27 3.5mm† Hex

Cannulated Femoral, Recon, & Supracondylar M8x1.25 6g/M7x1.0 6g WIN5 ✓ 3.5mm† Hex

Flexible Humeral M5x0.8 6g WIN12 ✓ 2.5mm† Hex

Cannulated Tibial M8x1.25 6g/M7x1.0 6g WIN5 ✓ 3.5mm† Hex

Unknown Zickel 5/16”-24 UNF-2A WIN7 ✓ 5/32”† Hex

Biomet® Ankle Arthrodesis & Uniflex® Tibial 5/16”-24 UNF-2A WIN7 ✓ 3.5mm† Hex

Knee Arthrodesis, Holland Femoral, Uniflex® Femoral, & Uniflex® Reconstruction

3/8”-24 UNF-2A WIN10 ✓ 5.0mm† Hex

Retrograde Femoral 5/16”-24 UNF-2A WIN7 ✓ 5.0mm† Hex

Encore® Trueflex® Humeral & Forearm #8-32 UNC-2B WIN15 ✓ 3.5mm† Hex

True/Fix® Distal Femoral, Prox Humeral, & True/Fix® Ankle Fusion

1/4”-20 UNC-2A WIN3 ✓ 3.5mm† Hex

TrueFlex® Tibial 3/8”-32 UNEF-2B WIN17 ✓ 3.5mm† Hex & 8.0mm† Hex & 1/4” sq.

Stryker®-Howmedica®-Osteonics®

T-2™ Humeral M6x0.75 6g WIN14 ✓ 2.5mm† Hex

Gross/Kempf® Femoral M10x1.5 6g WIN8 ✓ 3.5mm† Hex & 5.0mm† Hex

IC™ Nail Femoral, Tibial, & T-2 Tibial M8x1.0 6g WIN16 ✓ 3.5mm† Hex

T-2™ Femoral Antegrade/Retrograde M8x1.0 6g WIN16 ✓ 3.5mm† Hex & 6.0mm Hex & 1/4” sq.

Alta® Humeral 1/4”-20 UNC-2A WIN3 ✓ T20 Torx

Alta® Femoral 5/16”-24 UNF-2A WIN7 ✓ T25Torx

Zimmer® M/DN® All 5/16”-18 UNC-2A WIN6 ✓ 3.5mm† Hex

ZMS® Tibial & Humeral 1/4”-20 UNC-2A WIN3 ✓ 5.0mm† Hex

ZMS® Femoral 3/8”-16 UNC-2A WIN9 ✓ 5.0mm† Hex

Hansen-Street™, Harris®, Tibia®, Schneider® 1/4”-20 UNC-2B WIN1 ✓ 2.5mm† Hex

Neff Nail Large Hook WIN25 (MIWA15‡) Not Applicable

Unknown - Solid & Broken* IM Nails

Diameter 12.5mm-15mm Solid Nail Extractor 12.5mm-15mm WIN20 Not Applicable

Diameter 10mm-12.5mm Solid Nail Extractor 10mm-12.5mm WIN21 Not Applicable

Diameter 8mm-10mm Solid Nail Extractor 8mm-10mm WIN22 Not Applicable

Diameter 6mm-8mm Solid Nail Extractor 6mm-8mm WIN23 Not Applicable

Unknown Kuntscher Diameter 12.5mm-15mm Solid Nail Extractor 12.5mm-15mm WIN20 Not Applicable

Kuntscher Diameter 10mm-12.5mm Solid Nail Extractor 10mm-12.5mm WIN21 Not Applicable

Kuntscher Diameter 8mm-10mm Solid Nail Extractor 8mm-10mm WIN22 Not Applicable

Kuntscher Diameter 6mm-8mm Solid Nail Extractor 6mm-8mm WIN23 Not Applicable

*Broken: Nails broken mid-shaft or less †Reverse capture twist ‡Applies to upgrade kits only

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IXIM Nail Extractor Compatibility Matrix

Universal Orthopedic Extractio

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For more information on the Xtract-All® Nail (MKS1017) Winquist III Universal IM Nail Extraction System

Call us at 888-4-SHUKLA (888-474-8552) or visit www.ShuklaMedical.com

...Because Every Minute Counts®

T: 888-4-SHUKLAT: 888-474-8552F: 727-626-2770

[email protected]

Shukla Medical8300 Sheen DriveSt. Petersburg, FL 33709www.ShuklaMedical.com

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Surgical Technique Guide - Shukla Medical

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