BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TOMCAT CUTTER, FORMULA (5BX)

    MDR report key: 2053361 · Received March 16, 2011

    Report

    Report Number
    2648666-2011-00073
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE UNIT DURING AN ARTHROSCOPIC PROCEDURE ON THE ANKLE, THE TIP OF THE INTERNAL BLADE OF THE UNIT BROKE OFF INTO THE BONE OF THE PT. IT WAS FURTHER REPORTED THAT THE SURGEON NEEDED TO USE A DRILL TO RETRIEVE THE TIP FROM THE BONE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM TOMCAT CUTTER, FORMULA (5BX) CUTTER HRX STRYKER ENDOSCOPY PUERTO RICO 10260CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK