BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM VA LOCKING SCREW STARDRIVE 20MM

    MDR report key: 2855004 · Received December 3, 2012

    Report

    Report Number
    1719045-2012-01224
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING AN ORIF, DISTAL RADIUS. DURING THE PROCEDURE, THE SURGEON REMOVED A VA LOCKING SCREW FROM THE HEAD OF THE PLATE IN ORDER TO REDIRECT THE ANGLE OF THE SCREW. UPON ATTEMPTING TO RE-PLACE IT AT A DIFFERENT ANGLE AFTER RE-DRILLING WITH THE VA CONE GUIDE, THE SCREW WOULD NOT ENGAGE INTO THE HEAD OF THE PLATE. THE SURGEON ATTEMPTED TO USE A NEW SCREW, WITH THE SAME RESULT. THE SURGEON LEFT THIS PARTICULAR HOLE IN THE PLATE UNFILLED. THIS IS REPORT #2 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM VA LOCKING SCREW STARDRIVE 20MM VA LOCKING SCREW HRS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR