BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL

    MDR report key: 2241550 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03258
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 9, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CORROSION OF THE ROTOR BEARINGS WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE OVERHEATING REPORTED.

    Description of Event or Problem · 1

    THE MICRO DRILL WAS SENT IN FOR EVAL BECAUSE IT WAS OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A READILY AVAILABLE SPARE DEVICE WITHOUT ANY PROCEDURE DELAY; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK