BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL

    MDR report key: 3013359 · Received March 20, 2013

    Report

    Report Number
    0001811755-2013-00565
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 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 FOR VISUAL EXAMINATION, THE ROTOR ASSEMBLY WAS FOUND TO BE CORRODED AND THE PRELOAD BEARING MOUNT WAS STUCK ON THE ROTOR ASSEMBLY. THE MOTOR WAS REPLACED DUE TO THE ERROR AND THE DEVICE WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    THE MICRO DRILL WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. 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
    115922 MICRO DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1