BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT

    MDR report key: 2874115 · Received December 14, 2012

    Report

    Report Number
    1719045-2012-01366
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH RIGHT TFN CONSTRUCT ON (B)(6) 2011. PATIENT RETURNED TO THE DOCTORS OFFICE REQUESTING TO HAVE THE HARDWARE REMOVED DUE TO PAIN. X-RAY TAKEN ON AN UNKNOWN DATE REVEALED THE NAIL WAS BENT AND CRACKED ABOVE THE HELICAL BLADE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. DURING THE REVISION SURGERY, IT WAS NOTED THAT THE NAIL AS BROKEN OFF ABOVE THE HELICAL BLADE WITH THE REMAINDER OF THE NAIL LEFT IN THE FEMUR. AN EXTRACTION HOOK WAS USED TO REMOVE THE NAIL WITHOUT INCIDENT. THE HELICAL BLADE AND TWO SCREWS WERE NOTED TO BE INTACT AND WITHOUT DAMAGE. THE SURGEON FELT THE WRONG IMPLANT WAS USED. AFTER THE EXTRACTION, THE PATIENT WAS REVISED TO A TOTAL HIP REPLACEMENT WHICH WAS PREVIOUSLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/RIGHT TI CANN TROCH FIXATION NAIL HSB SYNTHES MONUMENT 6681454

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention