MAUDE Adverse Event Report: Arthrex, Inc. Self Bunching KL 1.8 FiberTak, Hip; NON-DEGRADABLE FIXATN FASTENER

Model Number	Self Bunching KL 1.8 FiberTak, Hip
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 03-sep-2026, a sales representative reported via email that an ar-3636h self-bunching 1.8 knotless hip fibertak soft anchor had an issue during use.The suture did not convert when it was shuttled through the eyelet.The anchor remained implanted in the patient; however, the suture was cut and an additional anchor was implanted to complete the procedure.This was discovered during a hip arthroscopy procedure on 27-aug-2026.The patient outcome was not reported.Additional information was received on 15-sep-2026: the failure occurred prior to the repair suture entering the conversion.No visible defects were noted on the suture, eyelet, or anchor.A replacement device of the same part number, ar-3636h, was used to complete the procedure.The surgery was delayed approximately 3 to 5 minutes.No portion of the implant or instrument broke during the event.The implant remained in place and the suture was cut.An additional 3 to 5 minutes of anesthesia was administered due to the procedural delay.No patient injury or adverse outcome was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: Self Bunching KL 1.8 FiberTak, Hip
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 50806128
• Report Number: 1220246-2026-04794
• Device Sequence Number: 16099629
• Product Code: MBI
• UDI-Device Identifier: 00888867362888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: Self Bunching KL 1.8 FiberTak, Hip
• Device Catalogue Number: AR-3636H
• Device Lot Number: 15517439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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