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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 2/14/2025, it was reported by an arthrex subsidiary employee via email that the sutures from an ar-2257 ac tightrope repair kit broke when passing it through the tunnel.When the surgeon slightly tensioned the sutures, they broke.The case was completed using another product.This was discovered during a shoulder arthroscopy procedure on (b)(6) 2025.Additional information was received on 2/25/2025: the case was completed using another ar-2257 ac tightrope repair kit.There was no delay in the case, and further anesthesia was necessary.
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 for the reported failure can be attributed to user-applied excessive force during the tightening process.

• 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: 21558724
• Report Number: 1220246-2025-00856
• Device Sequence Number: 4430879
• Product Code: HTN
• UDI-Device Identifier: 00888867026391
• UDI-Public: (01)00888867026391(11)240201(17)290131(10)30901
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 09/09/2025

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: 30901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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