MAUDE Adverse Event Report: ARTHREX, INC. KNEE FIBERTAK W/ FIBERTAPE; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNEE FIBERTAK W/ FIBERTAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2024
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-3750sp knee fibertak was not advancing and the inserter ended up bent with a broken fragment.The bone socket was drilled, and the surgeon used a mallet to impact the anchor.The anchor was not advancing great, but the inserter was bent when it was down to the hub and pulled back.The tie that was holding the implant snapped off, and the implant did not hold.The inserter had a broken piece, but the surgeon decided not to perform an x-ray.The surgeon was confident the piece of inserter was either embedded in the patient's bone or outside of the patient.Everything else was removed from the patient, and another ar-3750sp knee fibertak was used to complete the case.This was discovered during an anterolateral ligament repair procedure on (b)(6) 2024.The case was delayed less than fifteen minutes.
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: KNEE FIBERTAK W/ FIBERTAPE
• 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: 20156772
• Report Number: 1220246-2024-07412
• Device Sequence Number: 8301182
• Product Code: MBI
• UDI-Device Identifier: 00888867434769
• UDI-Public: 00888867434769
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• 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): 06/24/2025

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: KNEE FIBERTAK W/ FIBERTAPE
• Device Catalogue Number: AR-3750SP
• Device Lot Number: 15154719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• 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
• Patient Sex: Unknown