BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM MEDULLARY REAMER HEAD

    MDR report key: 2062606 · Received April 8, 2011

    Report

    Report Number
    1719045-2011-00153
    Event Type
    Injury
    Date Received
    April 8, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH AN UNKNOWN TIBIA NAIL ON (B)(6) 2010. PATIENT COMPLAINED OF PAIN. X-RAY TAKEN ON AN UNKNOWN DATE SHOWED THE REAMER HEAD WAS STILL IN THE PATIENT. THE NAIL AND THE REAMER HEAD WERE REMOVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11.0MM MEDULLARY REAMER HEAD MEDULLARY REAMER HEAD HSB SYNTHES MONUMENT NA 2163287

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention NAIL