SURGICAL TECHNIQUE

SHARC-FT® AND TAYLOR STITCHER®

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SHARC-FT AND TAYLOR STITCHER

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

Taylor Stitcher

Targeting needleTargeting system

STN (Superelastic Transosseus Needle)

Knob

Proximal handle

Screw cap

The implantable device Sharc-fT is intended for the treatment of rotator cuff tears. It is designed both for arthroscopic or open surgery through the use of the dedicated instrument Taylor Stitcher.

Sharc-FT consists of a distal eyelet that can be deformed elastically and a proximal head developed to allow a lateral support against the humeral cortical bone in order to stabilize the device.

distal eyelet

Proximal eyeletSupporting underhead

Inserter siteSharc-FT

system allows location of the medial transosseous exit hole.Taylor Stitcher is supplied with three additional tools that complet its use: an inserter, a punch and a multipurpose tool for fitting/removing the STN needle. The inserter allows implantation of the Sharc- fT device. The punch instead allows a hole to be made where placing the Sharc-fT device. finally, the multi-purpose tool allows you to assemble and to disassemble the STN for any cleaning and replacement operations requested.

Super-elastic Transosseous Needle (STN) assembled on the instrument Taylor Stitcher allows to make one or more transosseous tunnels having in common a lateral entry hole, on which will be inserted the implantable device Sharc-fT, and one or more medial exit holes. STN needle, thanks to its super-elasticity, is able to recover its original shape and making transosseous curved tunnels. The use of the targeting needle assembled on the targeting

Warning. This description alone does not provide sufficient background for direct use of the instrument set. Instruction by a surgeon experienced in handling these instruments is highly recommended.

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

SURGICAL TECHNIQUE

Patient positioning

Surgical procedure

The patient should be positioned in beach chair or lateral decubitus positions.

1. Perform the bursectomy taking care to release the deltoid fascia and the lateral bursa, prepare the margin of the lesion. Perform the bony trench close to the cartilage margin.

Warning.This description alone does not provide sufficient background for direct use of the instrument set. Instruction by a surgeon experienced in handling these instruments is highly recommended.

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

SURGICAL TECHNIQUE

2. Align the targeting needle with the longitudinal axis of the humerus to find the correct lateral position of Sharc-fT as shown in the figure. Use the punch instrument to perform the Sharc-fT entry hole.

17-18 mm

3. Load on the distal eyelet of the Superelastic Transosseous Needle (STN) a monofilament suture USP 1 (4 metric). Turn the proximal handle counterclockwise up to the rotation stop to get only the tip of the STN outside the sleeve.

Twist

Pull back

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

SURGICAL TECHNIQUE

4. Put the distal end of the Taylor Stitcher on the previously prepared hole. Insert the targeting needle through the targeting guide and control that its tip is pointing the desired exit area; if the position isn’t what was expected, extract the targeting needle completely, correct the orientation of Taylor Stitcher and try again until you find the right position of the STN exit in the footprint. Be careful to screw in the targeting needle completely in order to get a correct targeting indication.

5. Turn the Taylor Stitcher proximal handle clockwise (2 turns). Gently hammer the back protruding knob to push over the STN about 2cm.

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

SURGICAL TECHNIQUE

6. Repeat the previous step till the STN protrudes 1cm out over the footprint.

7. Turn the proximal handle counterclockwise (1/2 turn) to relax the monofilament suture for an easy capture with a grasper. Lock the monofilament with the grasper. Extract the targeting needle, turn the proximal handle counterclockwise until the STN will be out of the bone.

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

SURGICAL TECHNIQUE

9. Put together the Sharc-fT on the insertion tool using the retention suture as showed in the figure. Load up to 4 high resistance sutures USP 2 (metric 5) on the Sharc-fT distal eyelet.

8. To perform further transosseous tunnels repeat steps from 3 to 7. Be careful to stay at least 1cm apart from previously done medial exit holes.

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

SURGICAL TECHNIQUE

11. Pull the high resistance sutures to allow the Sharc-fT to be positioned correctly by passing through the deltoid. Insert Sharc-fT in the prepared hole, a gently hammering could be required. Push the supporting underhead of Sharc-fT to get a cortical contact avoiding that falls it through the cortex. Unlock the device with the insertion tool leaving in place the retention suture in the proximal eyelet of Sharc-fT.

10. Tie the high resistance suture limbs to the correspondent monofilament suture shuttle. Pull the medial limbs one at a time for an easier access through the tunnels. We recommend a superolateral portal to pull the sutures.

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

SURGICAL TECHNIQUE

12. Pass all suture limbs through the cuff and tie the knots.

13. Bring to the anterior portal the anterior limb of the retention suture while its posterior limb and one strand for each suture in the lateral portal. Tie the sutures strands out of the lateral portal with the posterior limb of the retention suture, one knot for each suture for an easier pass.

SHARC-FT AND TAYLOR STITCHER | Surgical technique | NCS Lab Medical Devices Factory

SURGICAL TECHNIQUE

15. Tie the knots.

14. draw the suture strands through the proximal eyelet by pulling the anterior limb of the retention suture.

NCS LAB Medical Devices Factory is a brand of NCS Lab Srl.

via Pola Esterna 4/12 - 41012, Carpi (mo) ItalyTel e fax +39 059 669813

CATALOG

CODE DESCRIPTION QUANTITY PACKAGE CND RDMP005_AS014 Sharc-FT 1 Sterile, single envelope P09120102 393320

CODE DESCRIPTION QUANTITY PACKAGE CND RDMP005_AS050 Sharc-FT KIT

(1 Sharc-FT + 1 package with 2 Assut Ultra Faiber USP 2 - 5 metric sutures)

1 Sterile, single envelope

P091299 47863

CODE DESCRIPTION QUANTITY PACKAGE CND RDMP005_AS034 Kit Taylor Stitcher 1 Non sterile P091280 517408

CODE DESCRIPTION QUANTITY PACKAGE CND RDMP005_AS034_01 Taylor Stitcher 1 Non-sterile K0399 900854P005_AS034_02 Sharc-FT Insertion tool 1 Non-sterile K0399 900954P005_AS034_03 Punch tool TS 1 Non-sterile K0399 900974P005_AS034_04 Multi-purpose tool TS 1 Non-sterile K0399 901014

P005_AS034_05 Targeting system TS 1 Non-sterile K0399 901074P005_AS034_06 Targeting needle TS 1 Non-sterile K0399 901114P005_AS034_07 Screw cap TS 1 Non-sterile K0399 901135P005_AS034_08 Screws TS 1 Non-sterile K0399 901174P005_AS034_09 Dedicated sterilization box TS 1 Non-sterile K0399 901214

CODE DESCRIPTION QUANTITY PACKAGE CND RDMP005_AS034_10 Superelastic Transosseous

Needle (STN)3 Non sterile K0399 901254