BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2121159 · Received May 4, 2011

    Report

    Report Number
    1811755-2011-01576
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS DUPLICATED DURING FAILURE ANALYSIS; THE DEVICE OVERHEATED DURING TESTING. FURTHER INVESTIGATION REVEALED A DAMAGED MOTOR, ROTOR, DRIVESHAFT AND OTHER COMPONENT PARTS. ROTOR RUB, DAMAGED MOTOR AND SPINDLE HOUSING WERE IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. 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 TESTING. THE EVENT OCCURRED DURING A ROUTINE MAINTENANCE VISIT. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    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