BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2101958 · Received May 18, 2011

    Report

    Report Number
    1811755-2011-01792
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE OVERHEATED DURING PERFORMANCE TESTING. VISUAL EXAMINATION REVEALED WORN/DAMAGED MOTOR, ROTOR, DRIVE SHAFT AND SPINDLE HOUSING. ROTOR ROB, DAMAGED MOTOR CARTRIDGE AND SPINDLE HOUSING WERE IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. THE ROTOR COUPLER TRANSMITS TORQUE TO THE DRIVE SHAFT, AS A RESULT, ANY FAILURE OF THE COUPLER CAN CAUSE THE DRIVE SHAFT AND THE ROTOR TO STICK. THIS CAN LEAD AN INCREASE IN FRICTION BETWEEN THE MOVING COMPONENTS THUS RESULTING IN INCREASED HEAT PRODUCTION AS DESCRIBED BY THE CUSTOMER. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO CIRCULATION.

    Description of Event or Problem · 1

    THE STRYKER CORE IMPACTION DRILL WAS SENT IN FOR EVAL DUE TO OVERHEATING DURING A PROCEDURE. NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE DEVICE; THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT ANY 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