BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 2070689 · Received April 15, 2011

    Report

    Report Number
    1811755-2011-01288
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE OVERHEATING WAS NOT DUPLICATED. HOWEVER, UPON DISASSEMBLY, THE ROTOR BEARINGS WERE CONFIRMED TO BE CORRODED AND AN O-RING SEAL WAS BROKEN. CORROSION DAMAGE TO THE PRESS PLUG AND THE MID SPEED MOTOR WAS ALSO NOTED. THE BROKEN O-RING WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. 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 EVENT WAS ASSOCIATED WITH THE DEVICE; 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