BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT F/PD

    MDR report key: 3140606 · Received May 31, 2013

    Report

    Report Number
    8030965-2013-02570
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    March 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND FURTHER INSPECTION OF THE MANUFACTURING PROCESS AND THE MATERIAL SHOWED NO DEVIATION TO SPECIFICATIONS. NO PRODUCTION ERROR WAS ESTABLISHED. THE VISUAL INSPECTION OF THE DEVICE SHOWS CLEAR SCORCH MARKS ON THE HOUSING. THE INVESTIGATION WAS NOT ABLE TO DETERMINE THE EXACT CAUSE AS MOST OF THE INSIDES OF THE BATTERY WERE ALSO DESTROYED. IT IS POSSIBLE THAT A SHORT CIRCUIT INSIDE THE BATTERY WAS CAUSE DUE TO THE EVENT DESCRIPTION ¿BATTERY CONTACT POINTS CAME INTO CONTACT WITH A METAL CAGE.¿ FURTHER INSPECTION OF THE MANUFACTURING PROCESS AND THE MATERIAL SHOWED NO DEVIATION TO SPECIFICATIONS. NO PRODUCTION ERROR WAS ESTABLISHED. THE INVESTIGATION DETERMINED THIS COMPLAINT TO BE INVALID.

    Description of Event or Problem · 1

    THE CONTACTS OF THE BATTERY PACK CAME INTO CONTACT WITH A METAL BASKET, CAUSING SMOKE AND A BURNING ODOR. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240836 BATT F/PD MOQ SYNTHES GMBH MC091216

    Patients

    Seq Age Sex Outcome Treatment
    1