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	Foreign Body In Patient (2687)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 18th june 2025, it was reported by an arthrex's employee via email that for an ar-3641-1, 2.6 mm knotless fibertak¿ anchor, the tip of the shaft broke during the procedure.This was detected after an unspecific procedure on (b)(6) 2025.The broken tip was not identified at the time of the surgery.The broken tip was identified on xray post operation.The patient was taken back to remove the tip of the inserter several hours later.The tip was removed and accounted for.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the x-ray picture, which shows the tip at the distal end of the shaft of the inserter in the patient.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.Per dfu-0054-eo e warnings 7.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.The quality of the bone encountered was 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 user-applied excessive force during the prying/leveraging of 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: 22500495
• Report Number: 1220246-2025-02861
• Device Sequence Number: 8468160
• Product Code: MBI
• UDI-Device Identifier: 00888867290952
• UDI-Public: (01)00888867290952(11)240725(17)290630(10)15292736
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K232973
• 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): 09/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641-1
• Device Lot Number: 15292736
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown