BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 1610157 · Received February 11, 2010

    Report

    Report Number
    1610157
    Event Type
    Injury
    Date Received
    February 11, 2010
    Date of Event
    November 30, 2009
    Report Date
    January 6, 2010
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (ELECTIVE) FOR OSTEOARTHRITIS. WHILE SURGEON WAS USING SYSTEM 6 SAGITTAL SAW, THE SAGITTAL SAW BLADE BROKE AT INSERTION POINT INSIDE THE POWER HANDSET WHILE BEING USED. SAW BLADE SEQUESTERED, SAGITTAL SAW WAS NOT, AND MODEL/LOT OF SAW IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER INSTRUMENTS SAGITTAL SAW BLADE GFA STRYKER INSTRUMENTS 4125127100 314110109330017D

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention