MAUDE Adverse Event Report: ARTHREX, INC. HIP FIBERTAK SUTR ANCH, W/ #2 FW CL; NON-DEGRADABLE FIXATN FASTENER

Model Number	HIP FIBERTAK SUTR ANCH, W/ #2 FW CL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
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 (b)(6) 2026, it was reported by an arthrex employee via (b)(4) that an ar-3600h hip fibertak suture anchor broke during the anchor insertion.This was discovered during a labrum repair with no patient harm.
Event or Problem Description
On 24-mar-2026 the sales representative provided the following additional information via email: ar-3600nd-3h knotless hip fibertak 1.7mm flex drill was used to prepare the bone socket for insertion of the implant.The bone quality of the patient was not provided.A piece of the instrument did break but all pieces were retrieved.
Additional Manufacturer Narrative
Additional information: b5, g3.

• Brand Name: HIP FIBERTAK SUTR ANCH, W/ #2 FW CL
• 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: 24145044
• Report Number: 1220246-2026-00277
• Device Sequence Number: 8841033
• Product Code: MBI
• UDI-Device Identifier: 00888867295476
• UDI-Public: (01)00888867295476(11)250609(17)300531(10)15448478
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: HIP FIBERTAK SUTR ANCH, W/ #2 FW CL
• Device Catalogue Number: AR-3600H
• Device Lot Number: 15448478
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2025
• 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