BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2722101 · Received August 24, 2012

    Report

    Report Number
    1811755-2012-03225
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    July 26, 2012
    Report Date
    July 26, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MFR, HOWEVER THE OVERHEATING COMPLAINT COULD NOT BE REPLICATED. EVAL OF INTERNAL COMPONENTS REVEALED THAT THE ROTOR WAS LODGED IN THE MOTOR ASSEMBLY DUE TO CORROSION CONTAMINATION. THIS CONDITION CAN RESULT IN EXCESSIVE FRICTION AND HEAT GENERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EVAL CONDUCTED BY A MFR FIELD SERVICE TECH, THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1