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	Positioning Failure (1158)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that the sutures were not threaded in correctly into the loop, so the thread/button did not hold.It was noticed after an x-ray was taken that the sutures did not hold and therefore on the (b)(6) 2025 an additional surgery was performed where the surgeon added an additional tightrope for fixation.
Event or Problem Description
Update 28-jan-2025: it was further reported as clarification that the tightrope threads above the button were not pulled through each other.The loop was on the left side and the two threads on the right were not pulled through the loop.The customer further confirmation that the reported device was discarded.
Additional Manufacturer Narrative
Additional information: b5, g3.

• 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: 23756111
• Report Number: 1220246-2025-05496
• Device Sequence Number: 15832866
• Product Code: HTN
• UDI-Device Identifier: 00888867340152
• UDI-Public: (01)00888867340152(11)250919(17)300831(10)15500855
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 15500855
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown