BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL RESECTION GUIDE RT

    MDR report key: 2192481 · Received June 30, 2011

    Report

    Report Number
    2249697-2011-00975
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    HOWMEDICA OSTEONICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIBIAL RESECTION GUIDE MODULAR CAPTURE RT: CAT# 6541-2-702, LOT# UNK, WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AN EVAL OF THE REPORTED DEVICES CANNOT BE PERFORMED AS THEY WERE NOT RETURNED TO THE MFR. SHOULD DEVICES OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUTTING BLOCK AND THE CAPTURE BECAME STUCK TOGETHER AND COULD NOT BE TAKEN APART. THEY WERE PULLED APART AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL RESECTION GUIDE RT INSTRUMENT LXH HOWMEDICA OSTEONICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other