MAUDE Adverse Event Report: ARTHREX, INC. FIBERLOCK SUSPENSION SYSTEM; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERLOCK SUSPENSION SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
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 (b)(6) 2024, it was reported by a sales representative via email that the implant inserter from an ar-8988-cp fiberlock suspension system bent upon insertion.When the surgeon malleted it in, the tip broke off.The broken pieces were removed, and another ar-8988-cp fiberlock suspension system was used to complete the case.This was discovered during a cmc arthroplasty procedure on (b)(6) 2024.Additional information received on 4/9/2024: the fibertak inserter broke during insertion.The case was only delayed briefly while opening the new kit.Additional anesthesia was unnecessary and the patient was not affected.
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 misuse due to excessive user-applied mechanical forces.

• Brand Name: FIBERLOCK SUSPENSION SYSTEM
• 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: 19219649
• Report Number: 1220246-2024-02653
• Device Sequence Number: 8138952
• Product Code: MBI
• UDI-Device Identifier: 00888867377875
• UDI-Public: 00888867377875
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• 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): 03/31/2025

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: FIBERLOCK SUSPENSION SYSTEM
• Device Catalogue Number: AR-8988-CP
• Device Lot Number: 14924724
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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