BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3970720 · Received April 29, 2014

    Report

    Report Number
    8031000-2014-00236
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE WAS DEFECTIVE. INSIDE OF THE DEVICE A RUST RING EMERGED AND THIS MAY TRIGGER HYGIENIC PROBLEMS. NO ADDITIONAL CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255555 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1