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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
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 02/13/2025, a distributor reported via email that an ar-3641 2.6 mm knotless fibertak anchor had the tape side of the shuttle suture broken off when trying to retrieve the tape to convert the anchor due to the shuttle anchor being stuck and would not slide.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 02/19/2025: the frayed suture was retrieved from the patient.Enough tension was accomplished with one knotless anchor, so they decided to forego the second that had broken.There was no case delay; therefore, no additional anesthesia was required.This was discovered during a remplissage of the hills sach lesion 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: 21459266
• Report Number: 1220246-2025-00643
• Device Sequence Number: 15501046
• Product Code: MBI
• UDI-Device Identifier: 00888867287457
• UDI-Public: (01)00888867287457(11)240617(17)290531(10)15274274
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: 15274274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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