BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE BLADE

    MDR report key: 2090238 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01304
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K011381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE U.S. MFR AND AN INVESTIGATION IS ANTICIPATED. A F/U REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THREE MICRODEBRIDER CUTTERS WERE NOT SPINNING PROPERLY, CAUSING THEM TO HEAT UP. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE, CAUSING A 20 MINUTE DELAY. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM AGGRESSIVE BLADE ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK