BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA TOM CAT CUTTER

    MDR report key: 2061852 · Received April 14, 2011

    Report

    Report Number
    2061852
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 14, 2011
    Manufacturer
    STRYKER CORP
    Product Code
    FZT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    METAL FRAGMENTS WERE NOTICED IN THE JOINT SPACE/SHOULDER AREA. PICTURES ARE AVAILABLE.======================MANUFACTURER RESPONSE FOR FORMULA TOMCAT CUTTER, FORMULA TOM CAT CUTTER======================I TOLD ASCENT THAT THE PACKAGING WAS NOT SAVED AND REFERENCED FROM ANOTHER PRODUCT IN STOCK. WE WILL KEEP PRODUCT UNTIL WE ARE CONFIDENT THAT THE PATIENT DOES NOT DEVELOP AN INFECTION OR OTHER COMPLICATION.======== REPORTER'S RESPONSE ======================ACCORDING TO THE REPORTER, THIS IS THE FIRST INCIDENT THEY HAVE WITH THE DEVICE. NO OBSERVABLE MANUFACTURING PROBLEM NOTED. THE METAL FRAGMENTS WERE NOT REMOVED FROM THE PATIENT. "AFTER IRRIGATION THE FRAGMENTS WERE EMBEDDED INTO THE TISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA TOM CAT CUTTER FORMULA TOMCAT CUTTER FZT STRYKER CORP 375-565-000 1116966-FROM OTHERS IN STOCK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR