BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 2584422 · Received May 18, 2012

    Report

    Report Number
    1811755-2012-01868
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTACT PINS IN THE POTTED TRIGGER ASSEMBLY WERE BURNT, AND THE GEARS ON THE FIRS STAGE DIDN'T ROTATE SMOOTHLY.

    Description of Event or Problem · 1

    THE CORE UNIVERSAL DRIVER WAS SENT FOR EVALUATION DUE TO OVERHEATING WHILE BEING TESTED. THERE WAS NO PT INVOLVEMENT, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE UNIVERSAL DRIVER HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK