BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT

    MDR report key: 3003487 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10231
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE STARDRIVE SCREWDRIVER BLADE WAS RECEIVED WITH THE EDGES OF THE STARDRIVE FORM ROUNDED. ALL SIX BLADES HAD PORTIONS OF THE TIP BROKEN OFF. THE REPORTED DAMAGE INDICATES A FORM OF ABUSE OCCURRED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MATERIAL, HARDNESS AND MEASURABLE DIMENSIONS WERE FOUND WITHIN SPEC. DUE TO THE NOTED DAMAGE, PHYSICAL DIMENSIONAL VERIFICATION COULD NOT BE COMPLETED. THEREFORE THE COMPLAINT IS INDETERMINATE FOR A MFG PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TINE ON THE STARDRIVE SCREWDRIVER BROKE DURING USE. ALL BROKEN PIECES WERE RETRIEVED AND THE CASE WAS COMPLETED WITHOUT PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85848 STARDRIVE SCREWDRIVER SHAFT HXX SYNTHES (USA) 5143771

    Patients

    Seq Age Sex Outcome Treatment
    1