BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4249591 · Received November 14, 2014

    Report

    Report Number
    1719045-2014-10587
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE REPORTED ONLY AS TWO YEARS PRIOR TO THIS REPORT. SYNTHES MANUFACTURED THE 11MM/130° TI CANN TROCH FIXATION NAIL, PART #456.417, AND LOT NUMBER 7012373 ON WORK ORDER #(B)(4). INITIALLY, THE PART WAS INSPECTED AND CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET #456FI410, REVISION ¿H¿. THE LOT WAS RELEASED TO THE WAREHOUSE AUGUST 24, 2012. THERE WERE NO MATERIAL REVIEW REPORTS, NONCONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE 11MM/130° TI CANN TROCH FIXATION NAIL WAS MADE TO THE SYNTHES DRAWING P/N 456.391, REVISION ¿D¿, RELEASED ON JULY 22, 2005. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE THAT THE PATIENT HAD A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE DONE ABOUT TWO YEARS AGO. THE HELICAL BLADE HAD BROKEN AND THERE WAS A NON-UNION NOTED. THE PATIENT WAS REVISED ON OCTOBER 22, 2014 AND THE BROKEN BLADE, NAIL AND A LOCKING SCREW WERE REMOVED WITH EASE. THE PATIENT WAS IMPLANTED WITH A COMPETITOR¿S PRODUCT. THERE WAS NO TIME DELAY WITH THE REMOVAL OF TFN IMPLANTS. NO ADDITION INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737789 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7012373

    Patients

    Seq Age Sex Outcome Treatment
    1