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

Model Number	FIBERLOCK SUSPENSION SYSTEM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2025
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 sutures from an ar-8988-cp fiberlock suspension system would not slide upon inserting the anchor.The surgeon had to pull the anchor out and a new implant was used.This was discovered during a procedure on (b)(6) 2025.Additional information requested on 3/27/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Complaint allegation is confirmed per the picture attached to the investigation, which shows the broken suture.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 excessive force used during suture passing/tightening /tensioning.
Event or Problem Description
Additional information: this was discovered during a cmc suspensionplasty procedure.The case was completed using another ar-8988-cp fiberlock suspension system.The case was only delayed for one minute without additional anesthesia.

• 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: 21752408
• Report Number: 1220246-2025-01168
• Device Sequence Number: 18553700
• Product Code: MBI
• UDI-Device Identifier: 00888867377875
• UDI-Public: (01)00888867377875(11)241118(17)291031(10)15349142
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 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: 15349142
• 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: 08/29/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown