BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE IMPACTION DRILL

    MDR report key: 1873614 · Received September 17, 2010

    Report

    Report Number
    1811755-2010-01195
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 24, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. A CONDITION OF THE DEVICE OVERHEATING WAS FOUND WHEN THE DEVICE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE SPINDLE HOUSING OR DRIVESHAFT ASSEMBLY, WHICH WERE BOTH REPLACED ALONG WITH THE MOTOR CARTRIDGE, BEARINGS, AND OTHER COMPONENTS. SERVICE WILL REPAIR AND RETURN THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE PRODUCED A TEMPERATURE ERROR DURING AN ORAL SURGERY. ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR CORE IMPACTION DRILL SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK