BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02149

    MDR report key: 3080482 · Received April 26, 2013

    Report

    Report Number
    2520274-2013-02149
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL SYSTEM (TFN) ON AN UNKNOWN DATE. POST-OPERATIVELY, ON AN UNKNOWN DATE, PATIENT EXPERIENCED LATERAL PAIN WHERE THE HELICAL BLADE PROTRUDES LATERALLY AND ISSUES WITH PAIN STANDING FOR EXTENDED PERIODS OF TIME. X-RAYS SHOWED THAT THE FRACTURE HAD HEALED AND THERE WAS NO BROKEN HARDWARE. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. AT THIS TIME, SURGEON REMOVED ONE UNKNOWN TFN LONG NAIL, ONE UNKNOWN DISTAL SCREW, ONE UNKNOWN END CAP, AND ONE UNKNOWN HELICAL BLADE, FROM THE LEFT LEG OF PATIENT WITHOUT INCIDENT. THIS REPORT IS FOR AN UNKNOWN LONG TFN. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183207 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention