BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE

    MDR report key: 3113440 · Received May 15, 2013

    Report

    Report Number
    1719045-2013-01435
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    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. ADDITIONAL PRODUCT CODE: HWC. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. 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 OR ON 4/18/13. 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 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215384 11MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE HSB SYNTHES MONUMENT 6384411

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention