BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER SYSTEM 6

    MDR report key: 3120063 · Received May 16, 2013

    Report

    Report Number
    3120063
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 16, 2013
    Manufacturer
    STRYKER INSTRUMENTS,DIV OF STRYKER CORP
    Product Code
    GFA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    STRYKER PERFORMANCE SERIES SAGITTAL BLADE WAS ATTACHED TO THE SAW HANDPIECE. UPON USE THE END OF THE BLADE THAT WAS LOADED IN THE HANDPIECE BROKE INTO 2 PIECES AT THE ATTACHMENT SITE AND THE BLADE FELL OUT OF THE HANDPIECE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT TOTAL KNEE ARTHROPLASTY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217354 STRYKER SYSTEM 6 SAW, SAGITTAL BLADE GFA STRYKER INSTRUMENTS,DIV OF STRYKER CORP 6208 2173723

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L