BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HIGH TORQUE DRILL

    MDR report key: 2223266 · Received August 16, 2011

    Report

    Report Number
    1811755-2011-03010
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER. THE COMPLAINT COULD NOT BE DUPLICATED, SINCE THE DEVICE HAD SEIZED AND WASN'T ABLE TO RUN. INTERNAL COMPONENTS WERE EVALUATED, WHICH REVEALED SCORE MARKS AND PITTINGS ON THE ROTOR AND THE MOTOR ASSEMBLY.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE METAL PIECE OF THE HANDPIECE NEAR THE CORD OVER-HEATED DURING A PROCEDURE. THEY CHANGED THE HANDPIECE 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 UNIVERSAL HIGH TORQUE DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK