BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 1172708 · Received September 18, 2008

    Report

    Report Number
    2648666-2008-00107
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SHAVINGS IN THE JOINT DURING A PROCEDURE. THE SHOULDER WAS FLUSHED AND A DIFFERENT STRYKER BLADE WAS USED. THE SURGERY WAS DELAYED BUT WAS ABLE TO CONTINUE AND WAS SUCCESSFUL. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) CUTTER ERL STRYKER ENDOSCOPY PUERTO RICO 08151CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK