BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 3150333 · Received June 6, 2013

    Report

    Report Number
    1719045-2013-01530
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). 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 TROCHANTERIC FIXATION NAIL CONSTRUCT ON AN UNSPECIFIED DATE. REPORTEDLY THE PATIENT FELL AND CONSEQUENTLY THE PATIENT SUSTAINED A NEW FRACTURE NEAR THE KNEE. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE. THE PATIENT WAS REVISED WITH A LATERAL ENTRY LONG RECON NAIL TO COVER THE OLD INJURY AND REPAIR THE NEW FRACTURE. REPORTEDLY ALL HARDWARE WAS INTACT. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249684 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE HSB SYNTHES MONUMENT 7096914

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention