BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3770232 · Received March 10, 2014

    Report

    Report Number
    8031000-2014-00126
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    June 10, 2013
    Report Date
    February 12, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 07/20/2011. EVALUATION OF THE DEVICE OBSERVED THE MOTOR WAS SEIZED, THE TRIGGER AND CONTROLLER BOARD WERE BOTH DEFECTIVE. THE MOTOR, THE TRIGGER BOARD AND THE CONTROLLER BOARD HAVE BEEN CHANGED. ALSO NOTED BOTH ATK WERE FUNCTIONAL AND FOR THIS REASON WON'T BE FURTHER INVESTIGATED. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE STOPPED WITHOUT REASON DURING SURGERY. 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
    143836 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASEPTIC TRANSFER KIT HOUSING: 5002045, 5001475| 206933, 205656| MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE: