BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT F/532.001+532.010 14.4VDC

    MDR report key: 3171648 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02971
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    March 8, 2012
    Report Date
    March 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    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. (B)(6). A REQUEST FOR THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN MADE. THE DEVICE WAS RECEIVED AND IT WAS CONFIRMED THAT THE BATTERY WAS DAMAGED. THERE IS EVIDENCE THAT THERE WAS A SHORT CIRCUIT EXTERNALLY CAUSED THE BURNING OF THE HOUSING. UNFORTUNATELY THE EXACT REASON OF THE DAMAGE COULD NOT BE RELIABLY DETERMINED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2012, IT WAS NOTED THAT THE BATTERY FAILED. IT IS UNKNOWN WHERE THIS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 DURING AN UNKNOWN SURGERY WHEN THE BATTERY WAS IN USE IT SUDDENLY GAVE A NOISE AND DIED. WHEN THE BATTERY WAS CHANGED IT WAS NOTICED THAT THERE WAS A HOLE IN THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272632 BATT F/532.001+532.010 14.4VDC MOQ SYNTHES GMBH D111006

    Patients

    Seq Age Sex Outcome Treatment
    1