BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE IMPACTION DRILL

    MDR report key: 1842079 · Received August 26, 2010

    Report

    Report Number
    1811755-2010-01045
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    April 8, 2010
    Report Date
    April 8, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVAL. A CONDITION OF THE DEVICE OVERHEATING WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH DEBRIS IN THE MOTOR HOUSING. THE MOTOR ASSEMBLY WAS REPLACED AND THE HANDPIECE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE DRILL EXCEEDED MAXIMUM TEMPERATURE DURING TESTING. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATIONS OF ADVERSE CONSEQUENCES FROM THE ACCOUNT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK