BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04117

    MDR report key: 3212860 · Received July 9, 2013

    Report

    Report Number
    2520274-2013-04117
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIXATION NAIL (TFN) ON (B)(6) 2011. ON AN UNKNOWN DATE, THE TOP OF THE NAIL HAD BROKEN OFF RIGHT ABOVE THE HELICAL BLADE. THE PATIENT HAD A MALUNION DUE TO THE IMPLANT. THE SURGEON REMOVED THE BROKEN NAIL, BLADE AND SCREW AND REPLACED THE PATIENT WITH A TOTAL HIP ON (B)(6) 2013. NO FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS EXTENDED 45 MINS BUT WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE UNKNOWN SCREW. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313533 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention