BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER

    MDR report key: 3845263 · Received June 3, 2014

    Report

    Report Number
    1719045-2014-10242
    Event Type
    Injury
    Date Received
    June 3, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: ADDITIONAL PRODUCT CODE: HWC. ADDITIONAL DEVICE INFO: EXPIRATION DATE: 02/2022. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN TROCHANTERIC FIXATION NAIL AND A NONUNION. THE PATIENT WAS ORIGINALLY TREATED FOR A FEMUR FRACTURE DUE TO A BONE LESION IN THE FEMUR (DUE TO METASTATIC CANCER) ON (B)(6), 2013. ON AN UNKNOWN DATE, DURING A ROUTINE FOLLOW-UP, THE SURGEON CONFIRMED VIA X-RAY THAT A NONUNION WAS PRESENT AND THE NAIL WAS BROKEN. THE SURGEON EXPLANTED ALL HARDWARE. THE PATIENT WAS IMPLANTED WITH ANOTHER NAIL AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY IN THE SURGICAL TIME. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324771 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 7327044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention