MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN; WASHER, BOLT, NUT

Model Number	KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder surgery the shaft got bent and could not be pushed in.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.-visual inspection of the knotless ac tightrope® open repair implant, identified that the threaded distal end of the shaft was stripped, the pec button was disassembled from the tip of the inserter, with sutures and plate button.-functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment of insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
• 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: 23478449
• Report Number: 1220246-2025-05023
• Device Sequence Number: 10329572
• Product Code: HTN
• UDI-Device Identifier: 00888867340152
• UDI-Public: (01)00888867340152(11)250604(17)300531(10)15446462
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220947
• 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): 12/30/2025

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: KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLAN
• Device Catalogue Number: AR-2372BLO
• Device Lot Number: 15446462
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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