BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE

    MDR report key: 3222885 · Received July 12, 2013

    Report

    Report Number
    1719045-2013-01772
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TFN AND HELICAL BLADE ON (B)(6) 2013. FOLLOW UP EXAM ON UNKNOWN DATE REVEALED THAT THE HELICAL BLADE HAD CUT OUT OF THE FEMORAL HEAD. PATIENT WAS ASYMPTOMATIC OF PAIN. ON (B)(6) 2013 PATIENT WAS RETURNED TO THE O.R. FOR REVISION OF THE TROCHANTERIC FIXATION NAIL (TFN) CONSTRUCT. NAIL, BLADE AND LOCKING SCREW WERE REMOVED. PATIENT WAS REVISED TO ENDOPROSTHESIS. PATIENT STATUS/OUTCOME WAS REPORTEDLY GOOD. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321707 11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE HSB SYNTHES MONUMENT 7262067

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention