BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGELED LONG SABER ATTACHMENT

    MDR report key: 2233196 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02652
    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
    ERL
    PMA / PMN Number
    K040300
    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 MFR AND UPON DISASSEMBLY OF THE UNITS, THE UNIT HAD DEBRIS PRESENT INTERNALLY. 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 ATTACHMENT OVERHEATED DURING A EDUCATIONAL LAB. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGELED LONG SABER ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 10091

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK