BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2102535 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01854
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 25, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE CUSTOMER'S COMPLAINT WAS DUPLICATED; THE DEVICE OVERHEATED DURING TESTING. UPON FURTHER INVESTIGATION, A DAMAGED ROTOR, SPINDLE HOUSING AND CORE DRIVE SHAFT ASSEMBLY WERE NOTED. THE ROTOR COUPLER TRANSMITS TORQUE TO THE DRIVESHAFT; A FAILURE OF THE COUPLER CAN CAUSE THE DRIVESHAFT AND THE ROTOR TO STICK TOGETHER RESULTING IN INCREASED FRICTION BETWEEN THE MOVING PARTS; THIS CAN LEAD TO INCREASED HEAT PRODUCTION. THE DAMAGED PARTS WERE REPLACED, PREVENTIVE MAINTENANCE DONE AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CORE IMPACTION DRILL WAS SENT IN FOR EVALUATION DUE TO OVERHEATING DURING A TOOTH EXTRACTION. NO ADVERSE EVENT WAS REPORTED, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT ANY PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK