BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2102506 · Received May 19, 2011

    Report

    Report Number
    1811755-2011-01853
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 25, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE CUSTOMER'S COMPLAINT WAS DUPLICATED; THE DEVICE OVERHEATED DURING PERFORMANCE TESTING. FURTHER INVESTIGATION REVEALED WORN/DAMAGED DRIVE SHAFT AND ROTOR WHICH WERE IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. THE DAMAGED PARTS WERE REPLACED, PREVENTIVE MAINTENANCE DONE AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE STRYKER CORE IMPACTION DRILL WAS SENT IN FOR EVALUATION DUE TO OVERHEATING DURING A PROCEDURE. NO ADVERSE EVENT WAS REPORTED; ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    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