BEUDAMED
    FDA Adverse Event Summary report: N

    FORMULA TOMCAT

    MDR report key: 1744325 · Received June 17, 2010

    Report

    Report Number
    1744325
    Date Received
    June 17, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 17, 2010
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DURING A SHOULDER ARTHROSCOPY, THE SURGEON REPORTED SEEING WHAT APPEARED TO BE METAL SHAVINGS FROM A STRYKER BRAND DISPOSABLE ARTHROSCOPY BLADE. NO PATIENT INJURY WAS NOTED, SINCE THE AREA WAS THOROUGHLY FLUSHED AND SUCTIONED TO REMOVE ALL TRACES OF THE METAL SHAVINGS. THE STRYKER REPRESENTATIVE WAS NOTIFIED AND ALL BLADES FROM OUR INVENTORY WERE REPLACED WITH BLADES FROM A DIFFERENT LOT.======================HEALTH PROFESSIONAL'S IMPRESSION======================THE SHAVER APPEARED TO HAVE LEFT METAL SHAVINGS.======================MANUFACTURER RESPONSE FOR DISPOSABLE ARTHROSCOPY BLADE, FORMULA======================THE MANUFACTURER HAS REPLACED ALL OF OUR INVENTORY OF THIS DEVICE WITH DEVICES FROM A DIFFERENT LOT NUMBER. OTHER THAN THAT THERE HAS BEEN NO OTHER RESPONSE FROM THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA TOMCAT DISPOSABLE ARTHROSCOPY BLADE HRX STRYKER ENDOSCOPY TOMCAT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR