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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 14th september 2026, it was reported by an arthrex employee via email that for an ar-2372blo, knotless ac tightrope® open repair implant, the surgeon tightened the adjustment suture using standard procedures, but the last 5 mm would not tighten.The loop was cut, and the implant was removed.This was detected during use in an unknown procedure on (b)(6) 2026.The procedure was completed successfully as a new one was opened and the procedure was redone without any issues.No significant surgery delay reported.All of the product/fragment was removed, and nothing remains in the patient.No additional anesthesia administered to the patient.No information about an instrument used to prepare/tap the bone socket for insertion of the implant.Bone quality of the patient is unknown.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50948534
• Report Number: 1220246-2026-04967
• Device Sequence Number: 13145310
• Product Code: HTN
• UDI-Device Identifier: 00888867340152
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/30/2026

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: 15656141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2026
• 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