BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFIX QA+#3/0 OC V-4

    MDR report key: 24331363 · Received February 13, 2026

    Report

    Report Number
    1221934-2026-00729
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    February 4, 2026
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705002481
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING LIGAMENT REPAIR SURGERY THREE (3) MICROFIX QA+#3/0 OC V-4 BROKE DURING USE. THE FIRST DEVICE BROKE OFF. A SECOND SUTURE WAS USED AND THE ANCHOR BROKE OFF. A THIRD SUTURE WAS USED AND THE ANCHOR BROKE OFF AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398212 MICROFIX QA+#3/0 OC V-4 FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 101ZJX 10886705002481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown