BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2090666 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01303
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE CUSTOMER'S COMPLAINT WAS DUPLICATED; THE DEVICE OVERHEATED DURING TESTING. FURTHER INVESTIGATION REVEALED CORROSION DAMAGE WITHIN THE MOTOR, ROTOR, PRESS PLUG AND OTHER COMPONENT PARTS. ACCORDING TO THE ANALYSIS NOTES, THE ROTOR WAS STUCK IN THE MOTOR DUE TO CORROSION; THIS INTERFERENCE MAY CAUSE FRICTION WHICH COULD LEAD TO THE OVERHEATING DESCRIBED BY THE CUSTOMER. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER CORE MICRO DRILL WAS SENT IN FOR REPAIR DUE TO OVERHEATING DURING A PROCEDURE. NO ADVERSE CONSEQUENCE WAS REPORTED; ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE 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