BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE

    MDR report key: 3810810 · Received March 21, 2014

    Report

    Report Number
    8031000-2014-00183
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE STOPPED WORKING. THE ISSUE OCCURRED DURING SURGERY AND THERE WAS PATIENT INVOLVEMENT AN ALTERNATE ZIMMER POWER SETS HAD TO BE OPENED TO FINISH SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170458 UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1