BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE

    MDR report key: 3172236 · Received June 5, 2013

    Report

    Report Number
    8031000-2013-00069
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE FAILED MULTIPLE TIMES DURING SURGERY, WHILE USING THE OSCILLATING SAW BLADE ATTACHMENT. IT WAS FURTHER REPORTED THAT SURGERY WAS DELAYED BY AN UNSPECIFIED AMOUNT OF TIME. THERE WAS NO REPORT HARM TO THE PT AND AN ALTERNATE DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249171 UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1