BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFIX QA+#3/0 OC V-4

    MDR report key: 19270416 · Received May 8, 2024

    Report

    Report Number
    1221934-2024-01512
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 22, 2024
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705002481
    PMA / PMN Number
    K150209
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. E3: REPORTER IS A J&J SALES REPRESENTATIVE. UDI: (B)(4). INVESTIGATION SUMMARY : THE PRODUCT HAS NOT RETURNED TO DEPUY SYNTHES MITEK, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT MICROFIX QA+#3/0 OC V-4 ANCHOR WAS DETACHED FROM THE INSERTER. ADDITIONALLY, THE IMAGE QUALITY IS POOR AND NO CLEAR OBSERVATION OF THE ANCHOR STATE COULD BE MADE. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE OBSERVED CONDITION OF THE MICROFIX QA+#3/0 OC V-4 WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE COULD BE TRACED TO THE PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE. AS PER INSTRUCTIONS FOR USE (IFU) DO NOT TWIST OR APPLY BENDING FORCE TO THE INSERTER. DOING SO MAY DAMAGE THE ANCHOR, SUTURE, OR INSERTER TIP, AND 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 COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES MITEK 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.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM CHINA THAT DURING A SURGICAL PROCEDURE OF THE FINGER IT WAS OBSERVED THAT THE MICROFIX QA+#3/0 OC V-4 ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100958 MICROFIX QA+#3/0 OC V-4 FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 197L583 10886705002481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown