BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER

    MDR report key: 1610153 · Received February 11, 2010

    Report

    Report Number
    1610153
    Event Type
    Injury
    Date Received
    February 11, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 6, 2010
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ELECTIVE RIGHT TOTAL KNEE REPLACEMENT. WHILE SURGEON WAS USING SYSTEM 6 SAGITTAL SAW, THE SAGITTAL SAW BLADE BROKE WHERE IT WAS INSERTED INTO THE SAW HANDLE. ALL PIECES OF BLADE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SYSTEM 6 SAGITTAL SAW/SAGITTAL BLADE GFA STRYKER INSTRUMENTS 4125-127-100 314110109334017D

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention