MAUDE Adverse Event Report: ARTHREX, INC. SUTURETAPE 1.3MM WH/BL & WH/BLK; POLYETHYLENE SYNTHETIC SUTURE

Model Number	SUTURETAPE 1.3MM WH/BL & WH/BLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/29/2023, it was reported by a sales representative via sems-06045007 that an ar-13999hdn hd scorpion needle with megaloader, ve5, had an issue.The surgeon was completing an aflex 301 patch over a rotator cuff, side-side repair.The surgeon placed and tied 3 suturetapes, starting anterolateral and moving posteriorly.On attempting to place a final suture tape on the posterolateral corner of the patch/cuff tissue, the distal 8-9mm of the hd scorpion needle broke off, cutting the suture.On pulling the scorpion out of the joint, the broken needle tip flew out and landed on the back scrub table.The surgeon stated after the case, ¿i felt the needle bend as i fired it through the patch.¿ the case was completed using another ar-13999hdn hd scorpion needle and several packs of ar-7501 with a delay of 4-5 minutes while retrieving and opening a new scorpion hd needle.There was no additional anesthesia needed.This was discovered during rotator cuff repair with a patch augmentation procedure on (b)(6) 2023.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle thus cutting the suture.

• Brand Name: SUTURETAPE 1.3MM WH/BL & WH/BLK
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18002086
• Report Number: 1220246-2023-08352
• Device Sequence Number: 20752559
• Product Code: GAT
• UDI-Device Identifier: 10888867288819
• UDI-Public: 10888867288819
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUTURETAPE 1.3MM WH/BL & WH/BLK
• Device Catalogue Number: AR-7501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown