MAUDE Adverse Event Report: ARTHREX, INC. KNEE FIBERTAK W/ FIBERTAPE; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNEE FIBERTAK W/ FIBERTAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2025
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 23-dec-2025, an arthrex subsidiary employee reported via email that following completion of an mpfl internal brace procedure, a postoperative x-ray revealed what appeared to be the shaft of the fibertak from an ar-3740sp double loaded knotless knee fibertak anchor.A thorough search was conducted, but the component was not located outside the patient.It was determined that the fragment remained within the bone tunnel, and the wound was reclosed.The anchor remained functional and was used to complete the procedure without further complications.The event resulted in a surgical delay of over one hour, and additional anesthesia was administered.The broken piece remains implanted in the patient.Additional information was received on 05-jan-2025: no additional surgery is planned to retrieve the piece.
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 user-related factors, such as misaligned insertion or prying and leveraging the device.

• Brand Name: KNEE FIBERTAK W/ FIBERTAPE
• 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: 24066634
• Report Number: 1220246-2026-00197
• Device Sequence Number: 9380899
• Product Code: MBI
• UDI-Device Identifier: 00888867434769
• UDI-Public: (01)00888867434769(11)250627(17)300531(10)15457343
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K251809
• 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,Followup
• Report Date (Section B): 05/18/2026

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: KNEE FIBERTAK W/ FIBERTAPE
• Device Catalogue Number: AR-3750SP
• Device Lot Number: 15457343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 04/29/2026; 05/15/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/30/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown