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

Model Number	DISPOSABLE KIT, KNEE FIBERTAKS
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
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 1/12/2024, it was reported by a sales representative via phone that an ar-3710 knee fibertaks disposable kit does not create a big enough bone hole for the insertion of the drill guide and fibertak.After the hole is created, the surgeon has difficulty implanting the fibertak to the point where the inserter of the fibertak ends up broken or with bent prongs.The broken fragments were contained within the drill guide, and nothing was loose inside the patient.The surgeon has attempted to implant an ar-3730sp double loaded knee fibertak, an ar-3740sp double loaded knotless knee fibertak and an ar-3770sp hybrid knee fibertak, all with the same results.This was discovered during a procedure on (b)(6)2024.
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 misaligned insertion.

• 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: 18652447
• Report Number: 1220246-2024-00796
• Device Sequence Number: 18193018
• Product Code: MBI
• UDI-Device Identifier: 00888867426016
• UDI-Public: 00888867426016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/08/2025

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: DISPOSABLE KIT, KNEE FIBERTAKS
• Device Catalogue Number: AR-3710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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