BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM ANGLED ATTACHMENT

    MDR report key: 4192358 · Received October 22, 2014

    Report

    Report Number
    0001811755-2014-03694
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED THROUGH FUNCTIONAL EVALUATION, DISASSEMBLY AND VISUAL INSPECTION. THE DEVICE FAILED FOR HEAT DUE TO A BREAKDOWN OF LUBRICATION. BROKEN DOWN LUBE MAY AFFECT THE COMPONENTS OF THE DEVICE CAUSING HEAT DUE LIMITED ROTATION. THE DEVICE WAS SCRAPPED AT THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE MICRO DRILL MEDIUM ANGLED ATTACHMENT WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE MICRO DRILL MEDIUM ANGLED ATTACHMENT WAS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674250 MICRO DRILL MEDIUM ANGLED ATTACHMENT DENTAL OPERATIVE UNIT AND ACCESSORIES EIA STRYKER INSTRUMENTS-KALAMAZOO 0411403683

    Patients

    Seq Age Sex Outcome Treatment
    1