BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 2070824 · Received April 15, 2011

    Report

    Report Number
    1811755-2011-01287
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, OVERHEATING WAS NOT DUPLICATED. HOWEVER, THE BEARING WAS DRY DEBRIS AND CORROSION WERE NOTED WITHIN THE DEVICE. THE DEBRIS AND CORROSION WERE IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. THE STRYKER MICRO DRILL MEDIUM STRAIGHT ATTACHMENT IS AN IRREPARABLE PART ONCE IT IS DISASSEMBLED; AS A RESULT, THE DEVICE WAS NOT RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS SENT IN FOR REPAIR DUE TO OVERHEATING DURING A ORAL MAX PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE; ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK