BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL LONG STRAIGHT ATTACHMENT

    MDR report key: 2101990 · Received May 18, 2011

    Report

    Report Number
    1811755-2011-01797
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE OVERHEATED DURING PERFORMANCE TESTING. VISUAL EXAMINATION REVEALED SEVERE CORROSION WITHIN THE INTERNAL COMPONENTS OF THE DEVICE. CORROSION DAMAGE AND DEBRIS WITHIN THE BALL BEARINGS WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. THE PRESENCE OF CORROSION AND DEBRIS WITHIN THE COMPONENTS LEADS TO INCREASE FRICTION BETWEEN THE MOVING PARTS; THIS CAN RESULT IN INCREASED HEAT PRODUCTION AS REPORTED BY THE CUSTOMER. CORROSION DAMAGE IS KNOWN TO OCCUR OVER TIME DUE TO IMPROPER STERILIZATION METHODS AND REPEATED AUTOCLAVE CYCLES. THE STRYKER MICRO DRILL LONG STRAIGHT ATTACHMENT IS NOT A REPAIRABLE DEVICE.

    Description of Event or Problem · 1

    THE STRYKER MICRO DRILL LONG STRAIGHT ATTACHMENT WAS SENT IN FOR REPAIR AND IT OVERHEATED DURING QUALITY INVESTIGATION. NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL LONG STRAIGHT ATTACHMENT DZJ STRYKER INSTRUMENTS KALAMAZOO 10113

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK