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

Model Number	FIBERLOCK SUSPENSION SYSTEM
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/4/2025, it was reported by a sales representative via email that an ar-8988-cp fiberlock suspension implant kit failed during a procedure on (b)(6) 2025.The patient was not harmed, and the case was completed using another arthrex implant.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 05/07/2025: a cmc repair using fiberlock was performed on (b)(6) 2025.During the procedure, a fibertak anchor failed to deploy inside the patient.The anchor was removed, and nothing broke inside the patient.To complete the case, another ar-8988-cp fiberlock suspension implant kit was used.The procedure had no delay, and no additional anesthesia was required.A drill from the kit was used to prepare the bone socket, and the patient's bone quality was assessed as average.The device cannot be returned for further evaluation.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided¿which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data¿arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically, improper surgical technique.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 21942475
• Report Number: 1220246-2025-01826
• Device Sequence Number: 20922394
• Product Code: MBI
• UDI-Device Identifier: 00888867377875
• UDI-Public: (01)00888867377875(11)241212(17)291130(10)15360998
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 10/06/2025

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: 15360998
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: Not provided; 09/30/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/30/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown