BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3831842 · Received March 6, 2014

    Report

    Report Number
    8031000-2014-00115
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 9, 2014
    Report Date
    February 10, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.,
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 THE UNIVERSAL MODULATOR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE SMALL SOCKET SCREW AT THE CONNECTION TO THE ATTACHMENT WAS BROKEN. THERE WAS NO PATIENT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135814 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GEY ZIMMER SURGICAL S.A., NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1