BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2102536 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01852
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ANALYSIS, THE CUSTOMER'S COMPLAINT COULD NOT BE DUPLICATED; THE DEVICE RAN ACCORDING TO SPECIFICATION. NO SECONDARY FAILURE WAS NOTED. THE DEVICE WAS CLEANED, LUBED, ADJUSTED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE MICRO DRILL WAS SENT IN FOR EVALUATION DUE TO OVERHEATING DURING A PROCEDURE. NO ADVERSE EVENT WAS REPORTED, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT ANY PROCEDURE DELAY.

    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