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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2025
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 (b)(6) 2025, it was reported by a sales representative via email that an ar-3636h self-bunching hip knotless 1.8 fibertak was placed and shuttled using the standard technique.The shuttle stitch was checked and confirmed to be sliding freely, but during the actual shuttling of the repair stitch, the shuttle stitch broke.This issue was discovered during a procedure on (b)(6) 2025.Additional information was received on 29-dec-2025: this occurred during a hip labral repair procedure.All fragments were retrieved.The case was completed using a replacement ar-3636h self-bunching 1.8 knotless hip fibertak soft anchor.The case was delayed; however, the duration and whether additional anesthesia was administered are unknown.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically improper bone preparation, excessive force, and/or incorrect surgical technique.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23975075
• Report Number: 1220246-2026-00078
• Device Sequence Number: 4554089
• Product Code: MBI
• UDI-Device Identifier: 00888867362888
• UDI-Public: (01)00888867362888(11)250826(17)300731(10)15488485
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 15488485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown