MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT, KNEE FIBERTAKS; DRILL BIT

Model Number	DISPOSABLE KIT, KNEE FIBERTAKS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-3710 disposable drill guide kit and (qty.2) of an ar-3770sp hybrid knee fibertak anchor failed while implanting using the drill guide kit.No further information was provided.This was discovered during a procedure, with no reported patient harm.Additional information was received on 02/11/2025: the ar-3710 disposable drill guide kit did not remove enough bone.It did not produce debris.The (qty.2) of an ar-3770sp hybrid knee fibertak anchor would not insert into the bone and would just bend when being hammered in.No instrument or implant broke during this issue.The case was completed using a 4.75 swivelock mpfl kit.There was no case delay or added anesthesia.There was no adverse effects on the patient reported.This occurred during a mpfl procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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: DRILL BIT
• 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: 21399530
• Report Number: 1220246-2025-00496
• Device Sequence Number: 15798286
• Product Code: HTW
• UDI-Device Identifier: 00888867426016
• UDI-Public: (01)00888867426016(11)240709(17)290630(10)15285002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/15/2025

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: 15285002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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