BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE

    MDR report key: 3080933 · Received April 24, 2013

    Report

    Report Number
    8031000-2013-00024
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 "WHEN MAKING A CUT ON THE HUMERUS HEAD FOR A REVERSE SHOULDER, THE SINGLE TRIGGER HAND PIECE FAILED TO FUNCTION." IT WAS REPORTED THAT THE CUSTOMER TRIED SWITCHING THE SAFETY ON THE OTHER SIDE, REPLACED THE BATTERY, AND INSERTED A DRILL ATTACHMENT. IT WAS REPORTED THAT NONE OF THESE ACTIONS MADE THE HAND PIECE WORK. THE CASE WAS FINISHED WITH AN ALTERNATE DEVICE AND THERE WAS NO REPORT OF PATIENT INJURY. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176759 UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE HAB ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1