BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II

    MDR report key: 3520698 · Received December 16, 2013

    Report

    Report Number
    8030965-2013-05535
    Event Type
    Malfunction
    Date Received
    December 16, 2013
    Date of Event
    November 18, 2013
    Report Date
    November 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRO CODE: MOQ. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED SURGEON WAS USING THE BATTERY OSCILLATOR II(EVALUATION SET)DURING A TOTAL HIP PROCEDURE, AND THE SAW DID NOT STOP WHEN THE SURGEON RELEASED THE TRIGGER. THERE WAS A FEW SECOND DELAY PRIOR TO THE SAW STOPPING. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657736 BATTERY OSCILLATOR II GEY SYNTHES GMBH 100042

    Patients

    Seq Age Sex Outcome Treatment
    1