BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL

    MDR report key: 1970373 · Received January 18, 2011

    Report

    Report Number
    1811755-2011-00147
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 23, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVAL AND AN INVESTIGATION WILL BE CONDUCTED. ADD'L INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THE MICRO DRILL WAS OVERHEATING AND NOISY DURING REGULAR QUALITY CHECK AT THE USER FACILITY. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL BONE CUTTING INSTRUMENT AND ACCESSORIES HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK