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

Model Number	FIBERTAK SUTURE ANCHOR
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
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
It was reported that during a bankart repair surgery the ar-3600 did not fit through aimer ar-3610ctc, as the red stabiliser peg got stuck.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6) 27-oct-2025: it was confirmed that when the surgeon used the device ar-3600 in the ar-3610ctc spear, the stabilization peg of the ar-3600 got stuck and broke inside the spear when the device was removed with force from the spear.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-complaint allegation is not confirmed.-visual inspection of the fibertak¿ suture anchor 1.6 mm with #2 fiberwire® cl (white/blue) noted that the red stabilization peg of the device does not have any issues.-functional testing was performed with reusable drill guides with references ar-3610#, and the device worked as required.No problem found.

• 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: 23426949
• Report Number: 1220246-2025-04902
• Device Sequence Number: 8281231
• Product Code: MBI
• UDI-Device Identifier: 00888867101890
• UDI-Public: (01)00888867101890(11)250625(17)300531(10)15456436
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: FIBERTAK SUTURE ANCHOR
• Device Catalogue Number: AR-3600
• Device Lot Number: 15456436
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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