BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 1163447 · Received September 10, 2008

    Report

    Report Number
    1811755-2008-00053
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZI
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AT THE MFR FOR EVALUATION, AND IT WAS NOTED THAT THE NOSE CONE HAD SIGNS OF MELTED PLASTIC ON IT. THE HANDPIECE PASSED THE QUALITY INSPECTION PROCEDURE WITHOUT ANY PROBLEMS. ANOTHER BUR GUARD WAS PLACED ON THE PRODUCT, AND THE PLASTIC ON THE NOSE CONE DID NOT COME INTO CONTACT WITH THE NEW BUR GUARD. THE MELTING OF THE BUR GUARD WAS MOST LIKELY CAUSED BY THE BUR GUARD BEING PUSHED UP ONTO THE HANDPIECE. WHEN THIS HAPPENS THE NOSE CONE COMES INTO CONTACT WITH THE BUR GUARD, AND THE FRICTION CAN MELT THE BUR GUARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WISDOM TOOTH REMOVAL, THE BUR GUARD MELTED AGAINST THE HAND PIECE, AND THE PATIENT RECEIVED A MINOR BURN AS A RESULT. THE BURN WAS TREATED WITH A TOPICAL OINTMENT, AND THE DOCTOR DID NOT INDICATE THAT THERE WOULD BE ADDITIONAL TREATMENT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL DRILL, POWERED, BONE DZI STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK