BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 3130397 · Received May 24, 2013

    Report

    Report Number
    0001811755-2013-01198
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, IT WAS FOUND THAT THE POTTED TRIGGER HAD PHYSICAL DAMAGE TO THE UPPER TRIGGER SHAFT, AND THE REAR MOTOR ASSEMBLY WAS FOUND TO BE CORRODED.

    Description of Event or Problem · 1

    THE CORE UNIVERSAL DRIVER WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, THE DEVICE CONTINUED TO RUN AFTER THE TRIGGER WAS RELEASED. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231596 CORE UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1