BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3172264 · Received June 5, 2013

    Report

    Report Number
    8031000-2013-00075
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PRESSURE IS APPLIED TO THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE SWING SOMETHING HARD SUCH AS BONE THE DEVICE STOPS OSCILLATING. THE REPORTED EVENT OCCURRED AT TIME DEVICE WAS RECEIVED AT A ZIMMER FACILITY AND WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249142 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1