BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4:1 MODULAR CAPTURE

    MDR report key: 2192490 · Received June 30, 2011

    Report

    Report Number
    2249697-2011-00982
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    HOWMEDICA ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, "WHILE USING THE CAPTURE CUTTING GUIDE, THE SURGEON PLACED THE GUIDE ON THE PT AND WHILE STARTING TO SAW THE CUTS, A METAL PIECE CAME OFF OF THE GUIDE. THE METAL PIECE WAS RETRIEVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4:1 MODULAR CAPTURE INSTRUMENT LXH HOWMEDICA ORTHOPAEDICS MAHWAH NA SB1V07

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other