BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 32MM

    MDR report key: 2863813 · Received December 10, 2012

    Report

    Report Number
    1719045-2012-01261
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THIS DEVICE IS USED FOR TREATMENT.

    Description of Event or Problem · 1

    WHILE INSERTING A SCREW INTO A DISTAL HUMERUS PLATED, THE HEAD OF THE SCREW BROKE OFF. IN ORDER TO REMOVE THE BROKEN SCREW, THE SURGEON HAD TO REMOVE A FEW OTHER SCREWS AND THE PLATE. ALL BROKEN FRAGMENTS WERE REMOVED AND THE PLATE AND SCREWS WERE REINSERTED IN ORDER TO COMPLETE THE PROCEDURE. REPORTEDLY, THE PATIENT HAD HARD BONE. SCREW WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM CORTEX SCREW SELF-TAPPING 32MM 3.5MM CORTEX SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR PLATE, SCREWS