BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED LONG SABER ATTACHMENT

    MDR report key: 2233162 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02650
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND THE UNIT FAILED THE TEMPERATURE TEST DURING THE CUT TEST. UPON DISASSEMBLY OF THE UNIT, THE BEARINGS HAD A GRITTY FEEL, MOST LIKELY DUE TO DEBRIS IN THE BEARINGS. DEBRIS CAN BIND UP OR LIMIT THE ROTATIONAL PROPERTIES OF THE DEVICE AND CAUSE FAILURES SUCH AS HEAT AND VIBRATION. THE FAILURE MODE WAS DETERMINED TO LIKELY BE DUE TO DEBRIS IN THE BEARINGS. THE AFFECTED COMPONENTS WERE LIMITED TO THE BEARINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE OVERHEATED. THE DEVICE WAS BEING USED IN AN EDUCATION LAB. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED LONG SABER ATTACHMENT HBE STRYKER INSTRUMENTS KALAMAZOO 09132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK