MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT, KNEE FIBERTAKS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DISPOSABLE KIT, KNEE FIBERTAKS
Medical Device Problem Codes	Fitting Problem (2183); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
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)2024, it was reported by a sales representative via email that an ar-3770sp hybrid knee fibertak was difficult to malleted in and did not fully seat.When the surgeon attempted to set the anchor, it pulled out.The surgeon was concerned that the patient's patella would be fractured with another ar-3770sp hybrid knee fibertak, so the case was completed using a 2.9 pushlock.This was discovered during an mpfl procedure on (b)(6)2024.Additional information received on 8/26/2024: an ar-3710 knee fibertak disposable kit was used to prepare the bone socket for the insertion of the ar-3770sp hybrid knee fibertak.The surgeon felt the drill was inadequate to accommodate the patellar bone's anchor.A second ar-3770sp hybrid knee fibertak was not used; instead, the surgeon completed the case with an ar-1923ps peek pushlock.The was delayed for five minutes without additional anesthesia.
Additional Manufacturer Narrative
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: DISPOSABLE KIT, KNEE FIBERTAKS
• 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: 20169777
• Report Number: 1220246-2024-07459
• Device Sequence Number: 7040513
• Product Code: MBI
• UDI-Device Identifier: 00888867426016
• UDI-Public: 00888867426016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 07/02/2025

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: DISPOSABLE KIT, KNEE FIBERTAKS
• Device Catalogue Number: AR-3710
• Device Lot Number: 15242083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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