BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE(TM) SCREWDRIVER T15

    MDR report key: 2900127 · Received January 7, 2013

    Report

    Report Number
    2520274-2013-00141
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 REMOVAL OF EXTERNAL FIXATOR AND AN ORIF OF PILON FRACTURE, THE SURGEON WAS TURNING THE STARDRIVE SCREWDRIVER AND INITIALLY IT BROKE INTO TWO PIECES AND THEN THE TWO PIECES SHATTERED INTO FRAGMENTS. THE BROKEN FRAGMENTS FELL INTO THE PATIENTS WOUND. THE SURGEON FLUSHED AND SUCTIONED THE WOUND TWICE. REPORTEDLY THE EXTERNAL FIXATOR WAS FOR A TEMPORARY FIXATION FOR AN OPEN FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8174 STARDRIVE(TM) SCREWDRIVER T15 STARDRIVESCREWDRIVER HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR