BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA.

    MDR report key: 1961199 · Received December 21, 2010

    Report

    Report Number
    2249697-2010-01838
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "AFTER REMOVING BLOCK, SURGEON NOTICED SPIKE WAS STILL IN PT'S FEMUR. SURGEON REMOVED SPIKE WITH HEMOSTAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA SB2V21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other