BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER

    MDR report key: 3061067 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-01100
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL AND HELICAL BLADE CONSTRUCT ON AN UNKNOWN DATE. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED A NON-UNION. IT IS NOT KNOWN IF THE PATIENT WAS COMPLAINING OF PAIN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED THE NAIL AND THE HELICAL BLADE. PATIENT WAS REVISED WITH ANOTHER TROCHANTERIC FIXATION NAIL (10MM X 360MM RIGHT 125 DEGREE) AND HELICAL BLADE (11MM X 85MM). AUTOGRAFT WAS COLLECTED WITH THE RIA SYSTEM AND THE GRAFT WAS IMPLANTED INTO THE NONUNION SITE REPORTEDLY. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162937 10MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER HSB SYNTHES MONUMENT 5759146

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention