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 Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(3) 2023, it was reported by a sales representative via phone that (qty.3) of an ar-3636h self bunching 1.8 knotless hip fibertak soft anchor (from two different lot numbers) and a (qty.2) of an ar-3638dhs disposbales kit, for knotless hip fibertak suture anchor, straight anchors were breaking in the bone when removing the inserter.The case was completed in debridement instead of repair, causing a case delay of 1 hour with additional anesthesia administered to the patient.All pieces of the anchors were removed, and the case was not completed.This was discovered during a hip arthroscopy labral repair procedure on (b)(3) 2023.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not confirmed.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 method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of 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: emily shafer ; 8009337001
• MDR Report Key: 18277562
• Report Number: 1220246-2023-09235
• Device Sequence Number: 6206976
• Product Code: LXH
• UDI-Device Identifier: 00888867295551
• UDI-Public: 00888867295551
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 15105361
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown