BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR

    MDR report key: 3130626 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02808
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THE COMPLAINT IS NOT REPORTABLE DUE TO THE COMPLAINT NOT MEETING THE DEFINITION OF AN MDR REPORTABLE EVENT. NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. THIS DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. SYNTHES IS RETRACTING MEDWATCH REPORT #: 2520274-2013-02808.

    Description of Event or Problem · 1

    DURING A TOTAL KNEE SURGERY ON (B)(6) 2013, A BATTERY OSCILLATOR STOPPED WORKING. THERE WAS NO DELAY IN SURGERY, A SPARE BATTERY OSCILLATOR WAS AVAILABLE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231260 BATTERY OSCILLATOR MOQ SYNTHES USA 3843

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR