BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 110MM

    MDR report key: 3113413 · Received May 15, 2013

    Report

    Report Number
    3003506883-2013-00222
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL AND HELICAL BLADE IN THE RIGHT FEMUR ON AN UNKNOWN DATE. THE PATIENT PRESENTED TO A DIFFERENT SURGEON FOR EXAM AND X-RAYS ON AN UNKNOWN DATE. X-RAYS REVEALED A NON UNION AND THE TFN NAIL WAS BROKEN AT THE DISTAL SCREW HOLE. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013. THE NAIL, HELICAL BLADE AND DISTAL SCREW WERE REMOVED AND THE PATIENT WAS REVISED TO A LATERAL ENTRY NAIL. PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215419 11.0MM TI HELICAL BLADE 110MM HSB SYNTHES ELMIRA 6760092

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention