BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 100MM

    MDR report key: 3845287 · Received June 3, 2014

    Report

    Report Number
    2520274-2014-11670
    Event Type
    Injury
    Date Received
    June 3, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SYNTHES USA
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324647 11.0MM TI HELICAL BLADE 100MM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention