BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 1111981 · Received August 12, 2008

    Report

    Report Number
    1719045-2008-00104
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 24, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PIECE OF THE REAMER HEAD BROKE DURING REAMING OF THE INTERMEDULLARY CANAL. SURGEON ATTEMPTED BUT WAS UNABLE TO RETRIEVE THE BROKEN PIECE. X-RAYS REVEALED BROKEN PIECE REMAINS IN FRACTURE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5MM MEDULLARY REAMER HEAD MEDULLARY REAMER HEADS HTO SYNTHES MONUMENT NA 2007697

    Patients

    Seq Age Sex Outcome Treatment
    1 NI REAMER SHAFT