BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 115MM

    MDR report key: 3091579 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02277
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CUTOUT OF THE HELICAL BLADE ON AN UNKNOWN DATE FOR A TROCHANTERIC FIXATION NAIL SYSTEM FOUR TO FIVE WEEKS POST-OPERATIVE. AN X-RAY WAS TAKEN, AND IT WAS NOTED THAT THE HELICAL BLADE HAD CUT THROUGH THE FEMUR HEAD. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 TO EXPLANT THE 11MM HELICAL BLADE 115MM AND WAS IMPLANTED WITH A 11MM HELICAL BLADE 100MM. THE ORIGINAL CANNULATED TROCHANTERIC FIXATION NAIL WAS LEFT IN THE PATIENT. PATIENT HAS NO ISSUES WITH THE NAIL. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194249 11.0MM TI HELICAL BLADE 115MM HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention