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

Model Number	FIBERLOCK SUSPENSION SYSTEM
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2025
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 11/3/2025, a sales representative reported via email that the fibertak anchor from an ar-8988-cp fiberlock suspension implant kit appeared defective, it wouldn¿t bunch up and looked damaged straight out of the package.This issue was discovered during a cmc arthroplasty procedure on (b)(6) 2025.The case was completed using another ar-8988-cp fiberlock suspension implant kit.Additional information was received on 11/12/2025: the white sheath of the fibertak anchor appeared damaged.It was heavily frayed and would not ball up properly when the surgeon attempted to deploy it.The case was not delayed, and no additional anesthesia was administered.No photos were taken of the event.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 is misuse or mishandling of the device during removal from the blister packaging, resulting in damage to the fibertak anchor prior to use.

• 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: 23707473
• Report Number: 1220246-2025-05305
• Device Sequence Number: 13419110
• Product Code: MBI
• UDI-Device Identifier: 00888867377875
• UDI-Public: (01)00888867377875(11)250602(17)300531(10)15445214
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/06/2026

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: 15445214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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