MAUDE Adverse Event Report: ARTHREX, INC. DOUBLE LOADED KNOTLESS FIBERTAK, KNEE; NON-DEGRADABLE FIXATN FASTENER

Model Number	DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
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 (b)(6) 2026, an arthrex subsidiary employee reported via email that three ar-3740sp double loaded knotless knee fibertak anchors were involved in an intraoperative issue during an acl reconstruction with let procedure on (b)(6) 2026.During the insertion of the first anchor, the inserter broke, preventing successful placement.A second anchor was then attempted; however, it did not secure within the bone tunnel and subsequently fell out.A third anchor was opened for use, but its inserter also broke during insertion.Despite this, the third anchor was successfully implanted, and the surgery was completed without further complications.The location of the broken fragment of the inserter remains unknown.Additional information was received on 26-jan-2026: the three ar-3740sp double-loaded knotless knee fibertak anchors were placed in the patella socket.For the first and third anchor complaints, the inserter tips broke during use, and the broken fragments were retrieved from the patient in both instances.The procedure experienced a brief delay of approximately 15 minutes.No additional anesthesia was administered.No adverse effects were reported.

• Brand Name: DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
• 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: 24308442
• Report Number: 1220246-2026-00511
• Device Sequence Number: 12069085
• Product Code: MBI
• UDI-Device Identifier: 00888867428041
• UDI-Public: (01)00888867428041(11)250828(17)300731(10)15489906
• 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
• Report Date (Section B): 06/04/2026

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: DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
• Device Catalogue Number: AR-3740SP
• Device Lot Number: 15489906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown