BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM ANGLED ATTACHMENT

    MDR report key: 1842021 · Received August 26, 2010

    Report

    Report Number
    1811755-2010-01037
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 29, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THERE WAS CORROSION BUILD UP IN THE NOSE OF THE ATTACHMENT, LIKELY CAUSED BY THE GAP BETWEEN THE BUR PILOT AND THE OUTER HOUSING. THE INSTRUCTIONS FOR USE WARN AGAINST USING SOLVENTS OTHER THAN THOSE SPECIFIED AND GIVES CLEANING AND STERILIZATION INSTRUCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM ANGLED ATTACHMENT BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO 09334

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK