MAUDE Adverse Event Report: ARTHREX, INC. 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY; BIO SOFT TISSUE FIXATN FASTNR

Model Number	2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that (2) ar-1322bcst single loaded suturetape s-tak assy failed.The first suturetak knotted at the nitinol loop and broke off in the patient's tissue.The second suturetak also knotted, and the nitinol wire popped off entirely.The surgeon was able to remove all the broken fragments.This was discovered during a brostrom repair procedure on (b)(6) 2024.The case was delayed about ten minutes.
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
The complaint allegation is confirmed.Based on the video provided from the field, it is evident that the suture bunches intra-operatively.Consequently, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 18992365
• Report Number: 1220246-2024-01715
• Device Sequence Number: 12647127
• Product Code: MAI
• UDI-Device Identifier: 00888867392069
• UDI-Public: 00888867392069
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140855
• 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): 02/03/2025

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: 2.4 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-1322BCST
• Device Lot Number: 15080184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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