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

Model Number	DISP KIT, CURVED, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/14/2024, it was reported by a sales representative via email that the implant got stuck in an ar-3638dhc disposable kit for knotless hip fibertak.The anchor got stuck and could not come out.A new anchor was used to complete the case.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 10/25/2024: the sales representative has reported that the ar-3636h self bunching 1.8 knotless hip fibertak inserter got stuck in the ar-3638dhc disposable kit.The case was completed using a new ar-3638dhc disposable kit and the ar-3636h self bunching 1.8 knotless hip fibertak was able to be implanted.
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 for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.

• Brand Name: DISP KIT, CURVED, 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: 20534348
• Report Number: 1220246-2024-08267
• Device Sequence Number: 15113543
• Product Code: LXH
• UDI-Device Identifier: 00888867295544
• UDI-Public: (01)00888867295544(11)240429(17)290331(10)15240702
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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, CURVED, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3638DHC
• Device Lot Number: 15240702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 06/11/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/18/2024; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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