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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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 26-jan-2026, a sales representative reported via phone that (3) ar-3636h self bunching 1.8 knotless hip fibertak®soft anchors shuttling stitches broke.This occurred during a hip labral repair on (b)(6) 2026.While shuttling the repair stitch, the shuttling stitch broke on all 3 devices.The devices were removed from the patient.The patient had good bone quality, which was prepped using the proper drill guide.The case was delayed about five minutes, and no additional anesthesia was administered.The case continued using (2) additional ar-3636h self bunching 1.8 knotless hip fibertak®soft anchors.There was no harm to the patient.

• 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: 24322248
• Report Number: 1220246-2026-00547
• Device Sequence Number: 15838140
• Product Code: MBI
• UDI-Device Identifier: 00888867362888
• UDI-Public: (01)00888867362888(11)240924(17)290831(10)15321361
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 05/18/2026

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: 15321361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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