BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL JOINT AGGRESSIVE PLUS CUTTER

    MDR report key: 1111953 · Received August 11, 2008

    Report

    Report Number
    2648666-2008-00082
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 9, 2008
    Manufacturer
    STRYKER PUERTO RICO
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAVER BLADE BROKE DURING ELBOW SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL JOINT AGGRESSIVE PLUS CUTTER CUTTER HRX STRYKER PUERTO RICO 07356CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK