BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II

    MDR report key: 3596141 · Received January 28, 2014

    Report

    Report Number
    2520274-2014-00333
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A POWER TOOLS EVALUATION WAS COMPLETED FOR THE DEVICE WITH LOT NUMBER 100059: THE BATTERY OSCILLATOR II MET ALL OPERATIONAL SPECIFICATIONS DURING TESTING, AND NO PROBLEMS WERE OBSERVED.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED.A POWER TOOLS EVALUATION WAS COMPLETED FOR THE DEVICE WITH LOT NUMBER 100042: THE BATTERY OSCILLATOR II MET ALL OPERATIONAL SPECIFICATIONS DURING TESTING, AND NO PROBLEMS WERE OBSERVED.AN EVALUATION FOR DEVICE WITH LOT NUMBER 100059 IS STILL BEING COMPLETED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MOQ: ADDITIONAL CODE. POSSIBLE LOT NUMBERS: #100059 AND /OR 10004: IT IS NOT KNOWN WHICH LOT HAD THE PROBLEM FOR THIS EVENT. THE DEVICES WERE RETURNED AND THE INVESTIGATION IS ONGOING. PLACEHOLDER.

    Description of Event or Problem · 1

    (B)(6). DURING A TOTAL HIP REPLACEMENT PROCEDURE, SURGEON STATED THE ATTACHMENTS WERE HARD TO PUSH INTO THE DRIVER HANDPIECE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61085 BATTERY OSCILLATOR II GEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR