BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 1132423 · Received August 22, 2008

    Report

    Report Number
    1719045-2008-00106
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. DEVICE HAS BEEN RECEIVED AND IS IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    DURING A RETROGRADE FEMORAL NAILING FOR A MIDSHAFT FEMUR FRACTURE, THE 8.5MM REAMING HEAD SHEARED OFF. SURGEON REPORTED FRAGMENTS REMAIN IN THE MEDULLARY CANAL NEAR THE LESSER TROCHANTERIC REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5MM MEDULLARY REAMER HEAD MEDULLARY REAMER HEADS HTO SYNTHES MONUMENT NA 5697107

    Patients

    Seq Age Sex Outcome Treatment
    1 NI REAMER SHAFT