BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3831813 · Received March 6, 2014

    Report

    Report Number
    8031000-2014-00107
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    January 30, 2014
    Report Date
    February 3, 2014
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 09/10/2012. EVALUATION OF THE DEVICE OBSERVED THE DOUBLE TRIGGER HANDPIECE WAS VISUALLY INSPECTED WITH NO DETECTION OF THE DEVICE POTENTIALLY BEING NONFUNCTIONAL. NO POWER SOURCE WAS RETURNED WITH THE DEVICE SUCH AS ATK OR FLASH BATTERIES OR ELECTRIC POWER SUPPLY. THE HANDPIECE WAS CONNECTED TO AN ELECTRIC POWER SUPPLY VIA AN ELECTRIC POWER SUPPLY CORD AND THE HANDPIECE RAN WITHIN SPECIFICATION. HOWEVER, THE MONITOR EMITTED A LOUD GRINDING SOUND DURING OPERATION. THE HANDPIECE MOTOR WAS DISASSEMBLED FOR A THOROUGH INTERNAL EXAMINATION. THE MOTOR BEARINGS WERE FOUND TO ROTATE VERY ROUGH, MORE SO THE TOP MOTOR BEARING. ALSO, THERE APPEARS TO BE MOISTURE THAT HAS ENTERED THE MOTOR AS THE MOTOR ARMATURE IS RUSTED. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE STOPPED WORKING DURING A TOTAL KNEE. THE HANDPIECE DID NOT COME BACK ON AFTER REPLACING THE BATTERY. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134797 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBL GEY ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1