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SpeedLockTM PEEK Knotless Implant,

Part of the OPUS® LabraFix® System

Unsurpassed in speed, precision, and ease of use for Bankart and SLAP repair surgery

System Includes:

· ·

SpeedLock PEEK Knotless Implant SpeedStitch® Suturing Device

Technique Guide

®

The System

The LabraFix System from ArthroCare® Sports Medicine's OPUS Collection is a groundbreaking system specifically designed for Bankart and SLAP repair. The LabraFix System enables the surgeon to perform a secure knotless repair of the labrum through rapid suture and anchor placement in an arthroscopic or mini-open approach. The system consists of two innovative devices:

The SpeedStitch Suturing Device

The SpeedStitch suturing device has an integrated grasper and suturing design that allows the surgeon to stabilize the labrum and capsular tissue and arthroscopically place a stitch in the tissue in a matter of seconds. The unique design of the SpeedStitch allows for easy access to all parts of the labrum circumference, along with a deep bite into the labrum and capsular tissue, enabling a fast and precise labral repair with capsular tightening.

SpeedStitch Suturing Device

Suturing Device Handle (OM-7000)

Suture Cartridge (OM-808X)

Needle Driver Lever Tissue Jaw Lever Ratchet Release Button

The SpeedLock Implant

The SpeedLock is a knotless interference fit implant that features OPUS automated internal suture lock and mechanical incremental tensioning. SpeedLock has independent bone lock, suture tensioning, and suture lock for the fastest, easiest, most precise labral repairs.

SpeedLock Implant

SpeedLock Implant Suture Ratchet Knobs Snare Ring Ratchet Release Button

Disposable Inserter Handle Deployment Handle

Suture Eyelet Snare Wire Loop

SpeedStitch Suturing Device Preparation

Loading the SpeedStitch Suturing Device Needle (OM-8850)

The needle used by the SpeedStitch is provided in a sterile package and housed inside a needle loader.

Step 1 To load the needle, first squeeze the silver

Step 1

Tissue Jaw Lever to expose the telescoping jaw, and insert the cylindrical end of the loader over the telescoping jaw.

Step 2 Push in the loader until its plastic tabs lock

into the slots on the sides of the barrel of the SpeedStitch.

Note:

Step 2

Never twist the needle loader or unloader. Only push or pull the loader axially along the barrel of the SpeedStitch.

Step 3 Next, squeeze the gold Needle Driver Lever

while holding the needle loader between thumb and forefinger. This maneuver will load the needle as well as eject the loader cartridge.

Note:

Step 3

The gold Needle Driver Lever will not actuate unless the silver Tissue Jaw Lever is actuated.

Step 4 Check that the SpeedStitch is ready to use

by actuating both the silver Tissue Jaw Lever and the gold Needle Driver Lever.

Step 4

Loading the SpeedStitch Suture Cartridge

Step 1 Load the Suture Cartridge by inserting

its plastic tube end into the barrel of the SpeedStitch.

Step 2 Continue feeding the plastic tube end into

the barrel until the metal tabs of the Suture Cartridge lock into the slots on the SpeedStitch barrel. Tug gently on the Suture Cartridge to ensure firm coupling. The SpeedStitch suturing device is now ready to use.

Step 1

Step 2

Surgical Technique

Placing the Labrum Stitch

Step 1a Close the jaw using the silver Tissue Jaw Lever

and insert the closed SpeedStitch suturing device into the glenohumeral joint through an anterior portal using an 8.2mm diameter cannula or greater. (Closing the telescoping jaw using the silver handle ensures that the jaw does not inadvertently catch tissue during insertion.)

Step 1b Insert the jaw of the suturing device into the

Step 1a

space between the glenoid bone and the labrum tissue.

Step 1c Open the jaw and manipulate the SpeedStitch

1a

1b

to engage the labrum tissue into the jaw. This usually requires a simple 90-degree rotation.

Step 2a Next, stabilize the tissue by squeezing the

silver Tissue Jaw Lever of the SpeedStitch to advance the telescoping jaw.

Step 2b Once the tissue is stabilized, squeeze the gold

Needle Driver Lever fully, followed by a gentle 1a release. The stitch is now placed.

Step 3

1b

Step 1b

1b

Step 1c

1c 1c

Release the tissue by pressing the Ratchet 1a Release Button on the bottom of the silver Tissue Jaw Lever. Then, close the jaw again and withdraw the SpeedStitch from the shoulder. To remove the suture from the suture hook, first partially open the silver Tissue Jaw Lever. Next, squeeze the gold Needle Driver Lever to expose the suture hook and pull the suture down and towards the handle. Clear the suture hook of any particles before placing another stitch.

Step 4

1b

1c

1c

Step 2a

2a

2a

Step 2b

2b

2b

Technique Tip: portal placement It is very important to have a good "angle of attack" for accessing the labrum, drilling holes into the glenoid, and placing the SpeedLock.

Technique Tip: labrum preparation An ArthroCare CoVator® ArthroWand® is specifically designed to resect the labral tissue from the glenoid.

Preparing the Bone Holes for the SpeedLock Implant:

The bone hole sites are planned by applying traction on the suture limbs. It is very important to drill the hole 2mm from the glenoid rim onto the articular surface of the glenoid. This helps create an anatomic "bumper" with the labrum. For superior implant sites, it is acceptable to drill on the glenoid rim.

Step 1 Through the same cannula, insert the SpeedLock Step 2 Next, insert the fluted 2.8mm SpeedLock drill

drill guide and place the distal tip at the desired site of the bone hole.

Note:

Drilling perpendicular is NOT required with the SpeedLock. However, drilling at too shallow of an angle will result in the drill "walking", or a superficially placed implant.

(yellow). Drill at least until the depth mark on the distal end of the drill is under the bone surface (visible in the arthroscopic view). It is OK to drill until the depth-stop at the proximal end of the drill is against the proximal end of the drill guide.

Note:

While creating the hole, the drill should be angled into the scapular neck to avoid drilling through the lip of the glenoid.

Note:

While drilling the hole, it is important to hold the sutures taut to avoid tangling of the sutures on the drill. Alternatively, bone holes may be created before the suture is placed.

Step 3 Once the hole is made, remove the drill and

insert the PathFinder® (blue) into the hole to maintain alignment while the SpeedLock is prepared for insertion.

SpeedLock

Technique Tip: drill angle Drill should be angled into the scapular neck, however a perpendicular angle is not required.

Deploying the SpeedLock Implant

Step 1a Pass both ends of the suture through the

Step 1a

Snare Wire Loop.

Step 1b Pull the Snare Ring distally in a straight line

away from the implant.

Step 1c Adjust the suture length so that approximately

2 inches (~5cm) of both suture ends extend from the distal end of the implant eyelet.

Step 2 Take up the suture slack by rotating the

Step 1b

Suture Ratchet Knobs with both hands in the direction of the arrows until suture is visible on the suture reel.

Step 3 Advance the implant down the portal until the

implant is just outside the drilled hole in the glenoid. Take up suture slack by turning the Suture Ratchet Knobs in the direction of the arrow on the body of the Inserter Handle. Important: · Ensure that the implant is oriented so that the suture emerges from the short slot on the inserter shaft straight towards the stitch in the labrum.

· Check that the entire length of the suture

Step 1c

2"

Step 2

is visible from the labrum to the implant to ensure there are no tissue bridges.

· Ensure that the implant is not splitting the

2"

sutures.

Step 3

Step 4 Maintaining a light grip on the Inserter Handle, tap

the end of the Deployment Handle with a mallet to drive the implant into the bone hole until the horizontal depth mark on the implant insertion shaft is under the articular surface of the glenoid. Important: Ensure that the SpeedLock implant and Inserter Handle are aligned with the bone hole to avoid bending or breaking the implant when inserting.

Step 5 Rotate Suture Ratchet Knobs to tension suture

and mobilize the labrum tissue to the glenoid. Continue rotating until desired tension is achieved.

Step 6 Detach the inserter handle by turning the

deployment handle approximately 3 full turns clockwise in the direction of the arrow. Remove the handle.

Step 7 Trim the sutures using the arthroscopic

Step 4

Step 5

MagnumWire® suture cutter.

The above sequence is repeated to place the desired number of implants to complete the labrum repair.

3x

Step 6 Step 7

Technique Tip: If a slight increase in tension is desired once the inserter handle is removed, reinsert the inserter handle into the appropriate hole until it is seated properly with the implant. Then, lightly tap the inserter handle until the desired tension is achieved. Do not use any other device to drive the implant down further as it may damage the implant.

To order or for more information, please contact your ArthroCare Sports Medicine representative or customer service at 800-797-6520. Visit our website at www.arthrocaresportsmedicine.com.

ArthroCare Sports Medicine 680 Vaqueros Avenue Sunnyvale, CA 94085-3523 main phone 408-736-0224 order entry 800-797-6520 order entry fax 888-994-2782 arthrocaresportsmedicine.com

ArthroCare Europe AB Skeppsbron 2 111 30 Stockholm Sweden phone +46 8 546 172 00 fax +46 8 546 172 39

[email protected]

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

© 2010 ArthroCare Corporation. All rights reserved. All trademarks, service marks, and logos listed herein are registered and unregistered trademarks of ArthroCare Corporation, its affiliates, subsidiaries, or a third party who has licensed its trademarks to ArthroCare.

P/N A2175 Rev A

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