MAUDE Adverse Event Report: ARTHREX, INC. AC TIGHTROPE REPAIR KIT, TITANIUM; WASHER, BOLT, NUT

Model Number	AC TIGHTROPE REPAIR KIT, TITANIUM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11th may 2024, it was reported by an arthrex employee via email that an ar-2257, ac tightrope¿ repair kit, titanium, was broken when the surgeon pulled the suture strand.This was detected during use in a fixation of shoulder dislocation surgery on (b)(6) 2024.The procedure was completed successfully as a new ar-2257 was used.
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 visual evaluation and 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 for the reported failure can be attributed to user error of the device due to excessive force being used when tensioning the sutures.

• Brand Name: AC TIGHTROPE REPAIR KIT, TITANIUM
• Common Device Name: WASHER, BOLT, NUT
• 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: 19478266
• Report Number: 1220246-2024-05099
• Device Sequence Number: 15229201
• Product Code: HTN
• UDI-Device Identifier: 00888867026391
• UDI-Public: 00888867026391
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: AC TIGHTROPE REPAIR KIT, TITANIUM
• Device Catalogue Number: AR-2257
• Device Lot Number: 28657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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