BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2042796 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01030
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE OVERHEATED. FURTHER INVESTIGATION REVEALED CORROSION DAMAGE TO THE ROTOR. A BROKEN PRESS PLUG AND DRIVE PIN WERE ALSO NOTED. THE MOTOR WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE FAILURE. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER MICRO DRILL WAS CALLED IN FOR REPAIR DUE TO OVERHEATING DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK