BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2241595 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03278
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE COMPLAINT OF OVERHEATING COULD NOT DUPLICATED AS THE DEVICE COULD NOT BE READ BY THE TPS OR CORE CONSOLES. UPON DISASSEMBLY, A WORN DRIVESHAFT BEARINGS AND BALL BEARINGS WERE OBSERVED. WORN BEARINGS CAN LEAD TO THE REPORTED CUSTOMER EVENT OF OVERHEATING DUE TO EXCESSIVE FRICTION BETWEEN THE ROTOR AND DRIVESHAFT. THE HEAT LIKELY LEAD TO NVRAM DAMAGE ON THE MOTOR FLEX AND THUS LOSS OF DEVICE RECOGNITION. THE DEVICE WAS REPAIR AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL WAS OVERHEATING AT THE BEGINNING OF AN IMPACTED MOLARS PROCEDURE. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN 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