BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFIX QA+#3/0 OC V-4

    MDR report key: 21003064 · Received December 23, 2024

    Report

    Report Number
    1221934-2024-04596
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    September 23, 2024
    Report Date
    December 23, 2024
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    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 IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4 H4: THE DEVICE EXPIRATION DATE, COMPLETE UDI AND DATE OF MANUFACTURE ARE UNKNOWN AT THIS TIME. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. J&J MEDTECH ORTHOPAEDICS THEN CONDUCTED VISUAL INSPECTION OF THE DEVICE RECEIVED. VISUAL INSPECTION REVELED THAT THE MICROFIX QA+#3/0 OC V-4 WAS RETURNED WITHOUT ITS PACKAGING, IT WAS RETURNED ONLY WITH ITS WHITE TRAY. THE DEVICE IS IN USED CONDITION, BIOLOGICAL MATTER CAN BE SEEN OVER THE HANDLE AND ANCHOR. THE ANCHOR BASE WAS BROKEN. THE BROKEN FRAGMENT WAS NOT RETURNED. THE REST OF THE DEVICE DOES NOT SHOW STRUCTURAL ANOMALIES. THE MANUFACTURER PERFORMED AN INVESTIGATION WITH THE FOLLOWING RESULTS; ADDITIONAL TWO PIECES WERE RECEIVED WITH COMPLAINT WHERE IT WAS FOUND THAT WITH SUTURE WAS PROPERLY WOUND AND THE DEVICES WERE CLEARLY USED SINCE THERE WAS BIOLOGICAL MATTER IN BOTH HANDLES. IN ONE OF THE DEVICES THE ANCHOR WAS STILL IN THE INSERTER, BUT THE ANCHOR WAS BROKEN. IN THE OTHER DEVICE WAS ALREADY OUTSIDE THE INSERTER AND THE TIP WAS BROKEN WITH THE ANCHOR STILL ATTACHED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITIONS OF THE MICROFIX QA+#3/0 OC V-4 WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDING AND SINCE THE DEVICE IS IN USED CONDITION, THE OUT OF THE BOX FAILURE CANNOT BE SUBSTANTIATED, HOWEVER THE POTENTIAL ROOT CAUSE FOR THE DEVICE DAMAGED CAN BE TRACED TO PROCEDURAL VARIABLES, SUCH AS HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE; BENDING FORCE WAS APPLIED AND CONSEQUENTLY CAUSE THE DEVICE DAMAGED. AS PER THE INSTRUCTIONS FOR USE; DO NOT TWIST OR APPLY BENDING FORCE TO THE INSERTER. DOING SO MAY DAMAGE THE ANCHOR, SUTURE, OR INSERTER TIP. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. THERE WAS A NON CONFORMANCES REGARDING THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MICROFIX QA+#3/0 OC V-4 DEVICE ANCHOR WAS DEFORMED. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN IN 2+ PIECES. IT WAS REPORTED THAT THE DEVICE HAD BEEN USED IN SURGERY AND THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED THAT A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2622258 MICROFIX QA+#3/0 OC V-4 FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 247L290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown