BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 3242212 · Received July 23, 2013

    Report

    Report Number
    0001811755-2013-01748
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF OVERHEATING WAS CONFIRMED DURING THE DEVICE EVALUATION. UPON VISUAL INSPECTION, SEVERE CORROSION WAS FOUND TO BE BUILT UP WITHIN THE ATTACHMENT AND THE UPPER BEARING WAS FOUND TO BE SHATTERED, WHICH IS THE PROBABLE CAUSE OF THE REPORTED OVERHEATING. THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, EXTRACTION OF TOOTH NO. 8, AT THE USER FACILITY THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THE PATIENT WAS BURNED AT THE LIP AND TREATED WITH AN OINTMENT AND PER THE DOCTOR ¿THE PATIENT BECAME WELL¿. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITH NO DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, EXTRACTION OF TOOTH NO. 8, AT THE USER FACILITY THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS OVERHEATING. IT WAS REPORTED THAT THE PATIENT WAS BURNED AT THE LIP AND TREATED WITH AN OINTMENT AND PER THE DOCTOR ¿THE PATIENT BECAME WELL¿. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342363 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 10302

    Patients

    Seq Age Sex Outcome Treatment
    1