BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3172015 · Received May 23, 2013

    Report

    Report Number
    3172015
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 23, 2013
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    KIJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    DURING A CABG, TWO STERNUM SAW BLADES INSTALLED IN A STRYKER SURGICAL HANDPIECE BROKE IN HALF WHILE IN USE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CABG.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229769 * SAW, ELECTRICALLY POWERED KIJ STRYKER INSTRUMENTS 298-97-100 317090112251027QE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR