BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL

    MDR report key: 2033714 · Received March 23, 2011

    Report

    Report Number
    1811755-2011-00915
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION TESTING, THE CUSTOMER'S COMPLAINT WAS NOT DUPLICATED. HOWEVER, FURTHER INVESTIGATION REVEALED CORROSION DAMAGE WITHIN THE PRESSPLUG, THE MOTOR, ROTOR AND THE BEARING. THE CORRODED MID MOTOR WAS IDENTIFIED AS THE PRIMARY PROBABLE CAUSE OF THE FAILURE. THE DAMAGED PARTS WERE REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER MICRO DRILL WAS SENT IN FOR REPAIR DUE TO OVERHEATING DURING TESTING. THERE WAS NO PT INVOLVEMENT, NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK