BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.9MM HEALX ADV SP BIOC ANCHOR

    MDR report key: 19427971 · Received May 30, 2024

    Report

    Report Number
    1221934-2024-01827
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Report Date
    May 30, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    MAI
    PMA / PMN Number
    K191242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. H11 ADDITIONAL NARRATIVE: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICE WAS DISCARDED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION OR THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCE WAS IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI:(01)10886705030576(10)8L44886(17)240831.

    Description of Event or Problem · 0

    IT WAS REPORTED BY JAPAN THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE, THE 4.9MM HEALX ADV SP BIOC ANCHOR DEVICE SUTURE FOR THE INNER ANCHOR WAS LOADED TO THE ANCHOR, WHEN THE ANCHOR WAS INSERTED INTO THE BODY THE SCREW MOVED TO THE TIP. ONCE IT WAS REMOVED FROM THE BODY, THE SURGEON ATTEMPTED TO PUT THE SCREW BACK IN. HOWEVER, IT COULD NOT BE INSERTED AND COULD NO LONGER BE USED FOR SURGERY. ANOTHER DEVICE WAS USED FOR SURGERY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DATE OF EVENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234543 4.9MM HEALX ADV SP BIOC ANCHOR FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI MEDOS INTERNATIONAL SARL 8L44886

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown