BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR MONOLITHIC SCREWDRIVER SHAFT

    MDR report key: 1760641 · Received July 9, 2010

    Report

    Report Number
    9617544-2010-00275
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WHEN THE DR WAS TRYING TO DRIVE THE SCREW INTO THE BONE THRU THE PLATE, THE SCREWDRIVER TIP SHEARED OFF INTO THE SCREW. THE BROKEN TIP WAS REMOVED WITH A LARGE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THOR MONOLITHIC SCREWDRIVER SHAFT INSTRUMENT HXX STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR