BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3172268 · Received June 5, 2013

    Report

    Report Number
    8031000-2013-00072
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER 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 WHILE THE SURGEON WAS USING THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE THE SURGEON HAD TO USE FORCE TO DRILL THE KEEL OF THE TIBIA OR A J&J KNEE PROSTHESIS, DURING WHICH THE DRILL STOPPED. IT WAS ALSO REPORTED THAT AFTER THE SURGERY, THE OPERATING ROOM NURSE FOUND A PART OF SCREW. THERE WAS NO REPORT OF PT INJURY OR MEDICAL/SURGICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249453 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1