BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3082416 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11184
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 29, 2011
    Report Date
    November 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS USING THE SMALL BATTERY DRIVE AND IT WAS WORKING INTERMITTENTLY. IT WAS THOUGHT THAT THE BATTERY AND THEY REPLACED THE BATTERY TWO TIMES. THE SCRUB NURSE ASKED FOR ANOTHER DRILL AND WHILE THE DRILL WAS ON THE BACK TABLE THEY NOTICED A BURNING SMELL. THE DRILL WAS HOT TO THE TOUCH, THE CASING WAS SEPARATED AND THEY REMOVED THE BATTERY WHICH HAD STARTED TO MELT. NO INJURY TO ANY HOSPITAL STAFF OR THE PATIENT. THE TWO BATTERIES THAT WERE SWAPPED OUT IN THE SMALL BATTERY DRIVE WILL NO LONGER HOLD A CHARGE. THEY REMOVED THE DRILL, CASINGS AND THE BATTERIES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184910 SMALL BATTERY DRIVE HWE SYNTHES GMBH 001044

    Patients

    Seq Age Sex Outcome Treatment
    1