BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 2053356 · Received March 16, 2011

    Report

    Report Number
    2648666-2011-00074
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE ON THE LEFT KNEE, THE BLADE OF THE UNIT BROKE OFF IN THE PT. IT WAS FURTHER REPORTED THAT THE SURGEON MADE A MINI LATERAL INCISION TO RETRIEVE THE BROKEN PIECE. THE PROCEDURE WAS DELAYED 30 MINUTES. IT WAS FURTHER REPORTED THAT THE EXPIRATION DATE ON THE UNIT IS 2015-10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) CUTTER HRX STRYKER ENDOSCOPY PUERTO RICO 10299CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK