MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DOUBLE LOADED FW CL; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK DOUBLE LOADED FW CL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 18th august 2025, it was reported by a distributor via email that for 2 units of ar-3600-2, fibertak¿ suture anchor with #2 fiberwire® cl (double loaded), the fibertak tip was broken during atfl repair fibula site insertion.2 anchors tip had the same issue.This was detected during use in an atfl repair procedure on (b)(6) 2025.The procedure was completed successfully with a third fibertak.The ar-3600nd-2 was used to drill the hole repeatedly.No fragment was left inside the patient.The bone density test is not a standard protocol for atfl repair case.
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 of the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: FIBERTAK DOUBLE LOADED FW CL
• 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: 22978791
• Report Number: 1220246-2025-03740
• Device Sequence Number: 18529158
• Product Code: MBI
• UDI-Device Identifier: 00888867206960
• UDI-Public: (01)00888867206960(11)230509(17)280430(10)15090475
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K181769
• 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): 12/18/2025

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: FIBERTAK DOUBLE LOADED FW CL
• Device Catalogue Number: AR-3600-2
• Device Lot Number: 15090475
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown