MAUDE Adverse Event Report: ARTHREX, INC. 2.6 MM KNOTLESS FIBERTAK ANCHOR; NON-DEGRADABLE FIXATN FASTENER

Model Number	2.6 MM KNOTLESS FIBERTAK ANCHOR
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
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 02/12/2025, a sales representative reported via email that an ar-3641 2.6 mm knotless fibertak anchor would not advance while inserting the anchor after correctly drilling for the anchor with multiple cycles.They decided to stop and see where they were and noticed that one of the prongs of the inserter had broken off.They retrieved the broken tip and completed the case with another ar-3641 2.6 mm knotless fibertak anchor (from a different lot: 15109786), following the same steps previously.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 02/18/2025: the case was delayed due to the opening of a new anchor.One to two minutes of added anesthesia was administered to the patient.No adverse effects on the patient were reported.This was discovered during a lateral epicondyle repair on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: 2.6 MM KNOTLESS FIBERTAK 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: 21467343
• Report Number: 1220246-2025-00662
• Device Sequence Number: 8658855
• Product Code: MBI
• UDI-Device Identifier: 00888867287457
• UDI-Public: (01)00888867287457(11)230329(17)280229(10)15073683
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641
• Device Lot Number: 15073683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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