BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRODRILL STRAIGHT ATT

    MDR report key: 1217226 · Received October 29, 2008

    Report

    Report Number
    1811755-2008-00080
    Event Type
    Injury
    Date Received
    October 29, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE HAND PIECE AND THE ATTACHMENT WERE RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. THE HAND PIECE WAS TESTED AND FOUND TO OPERATE WITHIN SPECIFICATIONS. THERE WAS A BUR LODGED INTO THE ATTACHMENT AND WHEN TESTED THE ATTACHMENT HEATED UP WITHIN SECONDS. UPON INVESTIGATION IT WAS NOTED THAT THERE WAS CORROSION THROUGHOUT THE UPPER PORTION OF THE ATTACHMENT AND THE BEARING WAS SHATTERED. THE INSTRUCTIONS FOR USE STATES THAT THE CUSTOMER SHOULD RUN THE ATTACHMENT BEFORE EVERY USE TO ENSURE THAT THE OPERATIONS OF THE PRODUCT IS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOOTH EXTRACTION THE PATIENT RECEIVED SECOND AND THIRD DEGREE BURNS TO THE LOWER LIP. IT IS UNKNOWN AT THIS TIME HOW THE BURN WAS TREATED AND IF THERE WILL BE ANY ADDITIONAL TREATMENT NEEDED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRODRILL STRAIGHT ATT BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO 07144

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention