BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASING FOR 12V BATTERY

    MDR report key: 3873124 · Received June 13, 2014

    Report

    Report Number
    3009450871-2014-10192
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED AS MAY 5, 2009. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(6). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE OBSERVED THAT THE DEVICE HAD CORROSION ON THE CONTACTS. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMMERSION DURING CLEANING, WHICH IS FAILURE TO FOLLOW THE DIRECTIONS FOR USE. THIS WAS MISUSE / ABUSE AND POSSIBLY USER ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE BATTERY CASING DEVICE HAD INTERMITTENT FUNCTION. THERE WAS A FOUR MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350009 CASING FOR 12V BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 015038

    Patients

    Seq Age Sex Outcome Treatment
    1