MAUDE Adverse Event Report: ARTHREX, INC. DISP KIT, STR, KNOTLESS HIP FIBERTAK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISP KIT, STR, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via phone that an ar-3636h self bunching 1.8 knotless hip fibertak inserter broke during implantation.Additionally, the straight drill guide from an ar-3638dhs disposables kit also broke inside the patient.All the broken fragments were removed, and the case was completed; nothing further was implanted.This was discovered during a hip labral repair procedure on (b)(6) 2024.The case was delayed around fifteen minutes.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause is misaligned insertion, which involves prying/leveraging the device during insertion.

• Brand Name: DISP KIT, STR, KNOTLESS HIP FIBERTAK
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19194025
• Report Number: 1220246-2024-02476
• Device Sequence Number: 7620871
• Product Code: LXH
• UDI-Device Identifier: 00888867295551
• UDI-Public: 00888867295551
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/10/2025

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: DISP KIT, STR, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3638DHS
• Device Lot Number: 15082382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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