MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK SUTURE ANCHOR; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK SUTURE ANCHOR
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
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 08/13/2025, an arthrex subsidiary employee reported via email that an ar-3600 fibertak suture anchor failed to secure upon insertion.A second attempt was made, but the tip of the anchor was damaged and could not be used, which led to its removal from the patient.The case was completed using a replacement ar-3600 fibertak suture anchor.There was no significant delay in the procedure, and no additional anesthesia was administered.No adverse effects were reported during or following the procedure.The issue was discovered during a procedure performed on (b)(6) 2025.
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 of 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: FIBERTAK SUTURE ANCHOR
• 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: 22945933
• Report Number: 1220246-2025-03711
• Device Sequence Number: 21116547
• Product Code: MBI
• UDI-Device Identifier: 00888867101890
• UDI-Public: (01)00888867101890(11)250516(17)300430(10)15437653
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: FIBERTAK SUTURE ANCHOR
• Device Catalogue Number: AR-3600
• Device Lot Number: 15437653
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown