BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 1970372 · Received January 18, 2011

    Report

    Report Number
    1811755-2011-00146
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE QUALITY INVESTIGATION TESTING THE DEVICE EXCEEDED THE MAXIMUM ALLOWABLE TEMPERATURE ON THE SPINDLE HOUSING AND THERE WAS EXCESSIVE NOISE AND VIBRATION FROM THE MOTOR. THE BEARINGS AND THE ROTOR WERE REPLACED. THE DEVICE HAS BEEN RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAND PIECE FAILED THE MAXIMUM TEMPERATURE RISE WHILE AT THE MFR. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK