BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER

    MDR report key: 3181380 · Received June 21, 2013

    Report

    Report Number
    1719045-2013-01499
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL (TFN) CONSTRUCT ON (B)(6) 2012. REPORTEDLY AFTER ONE MONTH, X-RAYS TAKEN ON AN UNSPECIFIED DATE LOOKED GOOD. ON (B)(6) 2013, THE PATIENT RETURNED TO THE DOCTOR COMPLAINING OF PAIN. X-RAY TAKEN ON AN UNSPECIFIED DATE REVEALED A BREAKAGE OF THE NAIL IN THE SLOT WHERE THE HELICAL BLADE GOES THROUGH THE NAIL IN THE UPPER PORTION. REPORTEDLY THE SURGEON THINKS THAT THIS WAS CAUSED BY A BY THE DRUG ACTONEL WHICH WAS PRESCRIBED BY THE PATIENTS FAMILY DOCTOR. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED THE TROCHANTERIC FIXATION NAIL, RE-REAMED THE BONE AND REVISED THE PATIENT WITH A LARGER NAIL WITH NO LOCKING SCREW IMPLANTED. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281681 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES MONUMENT 4561015

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention