BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2853949 · Received October 24, 2012

    Report

    Report Number
    1811755-2012-03877
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE BEARINGS ON THE DRIVESHAFT AND ON THE ROTOR ASSEMBLY DID NOT TURN SMOOTHLY AND THAT THE DRIVESHAFT AS WELL AS THE SPINDLE HOUSING AND THE ROTOR WERE WORN. THE FRICTION CAUSED BY THE WORN COMPONENTS AND IN THE BEARINGS ARE A PROBABLE CASE OF THE REPORTED OVERHEATING. THE DEVICE WAS REPAIRED BUT IT HAS NOT BEEN RETURNED TO USER FACILITY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY THE DRILL WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL 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