BEUDAMED
    FDA Adverse Event Summary report: N

    NI

    MDR report key: 2061193 · Received April 5, 2011

    Report

    Report Number
    8030965-2011-00140
    Date Received
    April 5, 2011
    Report Date
    March 28, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. LOT#: LOT NUMBER IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT WITH 11.0MM FEMORAL NAIL REPORTEDLY BROKEN. 'NO MATERIAL RECEIVED'. 'PATIENT IS CLAIMING AGAINST THE HOSPITAL AND AGAINST SYNTHES GMBH'. 'NO FURTHER INFORMATION AVAILABLE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI FEMORAL NAIL HSB SYNTHES (USA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention