BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM HEADLESS COMPRESSION SCREW-LONG THREAD 36MM

    MDR report key: 2772077 · Received October 4, 2012

    Report

    Report Number
    8030965-2012-00986
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K050636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A NAVICULAR ALS PROCEDURE, THE SURGEON WAS INSERTING THE SCREW AND AS THE SCREW GOT TIGHTER, THE SCREW HEAD BROKE OFF OF THE SCREW. THE SURGEON GAVE A GENTLE TAP WITH A HAMMER. THE SURGEON WAS UNABLE TO REMOVE THE SCREW SHAFT AND IT REMAINS IMPLANTED IN THE PATIENT. THE SCREW HEAD MAY HAVE BEEN DISCARDED OF. THERE WERE NO OTHER PIECES TO RETRIEVE FROM THE PATIENT. THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 5 MINUTES AND THE PROCEDURE WAS COMPLETED WITH NO NOTED ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM HEADLESS COMPRESSION SCREW-LONG THREAD 36MM 3.0MM HEADLESS COMPRESSION SCREW HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR