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

Model Number	FIBERLOCK SUSPENSION SYSTEM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2025
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 3/12/2025, it was reported by a sales representative via email that the fibertak from an ar-8988-cp fiberlock suspension system would not deploy across the far cortex.After reloading the anchor and verifying with fluoroscopy that it was across the far cortex, the anchor would not set.The case was completed by drilling another hole and using a new ar-8988-cp fiberlock suspension system.This was discovered during a cmc suspensionplasty procedure on (b)(6) 2025.Additional information requested on 3/28/2025.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information received: nothing broke inside the patient.The case was delayed several minutes while reloading the fibertak anchor and trying to redeploy the anchor.Additional anesthesia was not administered to the patient.The patient had good bone quality, we used the 3.0 mm drill to insert the swivelock in the base of the 1st metacarpal.
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 method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• 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: 21762140
• Report Number: 1220246-2025-01196
• Device Sequence Number: 12930680
• Product Code: MBI
• UDI-Device Identifier: 00888867377875
• UDI-Public: (01)00888867377875(11)241212(17)291130(10)15360995
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 09/08/2025

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: FIBERLOCK SUSPENSION SYSTEM
• Device Catalogue Number: AR-8988-CP
• Device Lot Number: 15360995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 08/29/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/02/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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