BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 3222694 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04227
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE MOST PROBABLE CAUSE FROM THE THREE REPORTED INCIDENTS IS INCORRECT TREATMENT. THE CONTAMINATED MACHINERY CAN REMAIN LYING FOR UP TO 6 HOURS. THE BLOOD REMAINS IN THE PUSHER GUIDES AND WILL DRY AND REMAIN THERE. ADDITIONALLY, THERE IS ONLY ONE MACHINE WASH WITHOUT PRIOR MANUAL CLEANING. DUE TO THE WASHING MACHINE THE PRINTER IS NOT OPERATED, THE MAJORITY OF THE RESIDUAL BLOOD REMAINS IN THE HANDLE GUIDANCE AND ACCUMULATES. SUBSEQUENTLY A SMALL QUANTITY OF BLOOD IS ENOUGH (WHEN THE MACHINE IS WARM) THAT WILL RESULT IN THE PUSHER BUTTON CLINGING ON THE NUMBER OF REVOLUTION 100%.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: WHILE MILLING AN ACETABULUM THE PUSH-BUTTON WOULD HANG UP. THE MILLING MACHINE WENT FORWARD AND COULD NOT BE STOPPED. THEREFORE THE MACHINE HAD TO BE TAKING OUT OF THE POOL. THEREBY MANY BONE DAMAGES AND SOFT PART DAMAGES OCCURED. THE POSITIONING OF THE ACETABULAR CUP WAS ADJUSTED WITH A SELECTION OF A LARGER IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321829 BATT-HANDPIECE MOD F/TRS GEY SYNTHES USA SER. NO.6668

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention