BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3002335 · Received March 7, 2013

    Report

    Report Number
    8031000-2013-00014
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOUBLE TRIGGER HANDPIECE FUNCTIONED WITH BATTERIES BUT NOT WITH THE ELECTRIC CONSOLE. IT WAS REPORTED THAT AS SOON AS A LITTLE BIT MORE LOAD WAS APPLIED WITH THE 10MM DRILL, THE HANDPIECE STOPPED WORKING. IT WAS REPORTED THAT THE BATTERY WAS SWITCHED ON THE SAME HANDPIECE TO FINISH THE SURGERY WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96800 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE MOQ ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1