BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE #6 4-IN-1 CUTTING BLOCK CAPTURED ASSY TRIA. E

    MDR report key: 2112791 · Received April 29, 2011

    Report

    Report Number
    2249697-2011-00610
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: "WHEN THE CUTTING BLOCK WAS REMOVED FROM THE FEMUR AFTER THE CUTS HAD BEEN PERFORMED ONE OF THE PINS FROM THE BACK OF THE BLOCK REMAINED LODGED IN THE FEMUR AND HAD TO BE REMOVED WITH SOME DIFFICULTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE #6 4-IN-1 CUTTING BLOCK CAPTURED ASSY TRIA. E INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA SB3M87

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other