MAUDE Adverse Event Report: ARTHREX, INC. SELF-PUNCHING TRIPLE LOADED FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SELF-PUNCHING TRIPLE LOADED FIBERTAK
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
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 08/25/2025, an arthrex subsidiary employee reported via email that an ar-3633sp fibertak sp suture anchor had failed during use.After the anchor was inserted into the bone hole, it was pulled out when tension was applied to the tape.Upon inspection, the anchor was found to be broken.The surgeon suspects the anchor may have not been properly secured to the shaft before insertion.The procedure was performed on (b)(6) 2025 and was completed using a replacement ar-3633sp fibertak sp suture anchor.No fragments remained inside the patient.There was no delay in the procedure, no additional anesthesia was administered, and no adverse effects were reported.The specific procedure type remains unknown, and no patient harm was reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to improper bone preparation, misaligned insertion, and prying and leveraging the device during use.

• Brand Name: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• 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: 23051277
• Report Number: 1220246-2025-03849
• Device Sequence Number: 10038533
• Product Code: MBI
• UDI-Device Identifier: 00888867369962
• UDI-Public: (01)00888867369962(11)241217(17)291130(10)15363119
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200341
• 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): 01/28/2026

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: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• Device Catalogue Number: AR-3633SP
• Device Lot Number: 15363119
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown