BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER

    MDR report key: 1610158 · Received February 11, 2010

    Report

    Report Number
    1610158
    Event Type
    Other
    Date Received
    February 11, 2010
    Date of Event
    December 21, 2009
    Report Date
    January 6, 2009
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GFA
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ELECTIVE LEFT TOTAL KNEE REPLACEMENT WITH INSERTION OF PROSTHESIS. WHILE SURGEON WAS USING THE SYSTEM 6 STRYKER SAGITTAL SAW, THE BLADE BROKE AT THE POINT OF INSERTION ONTO POWER HANDPIECE. BOTH BLADE & POWER HANDPIECE REMOVED FROM SERVICE. STRYKER SAGITTAL BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SYSTEM 6 SAGITTAL SAW GFA STRYKER INSTRUMENTS 4125-127-100 314110109330017D

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR