BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER

    MDR report key: 3101375 · Received May 9, 2013

    Report

    Report Number
    1719045-2013-01419
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    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 THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT WAS TREATED FOR AN INTERTROCHANTERIC FRACTURE WITH PLACEMENT OF A TROCHANTERIC FIXATION NAIL (TFN), HELICAL BLADE AND SCREW ON (B)(6) 2012. PATIENT COMPLAINED OF PAIN. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. IT WAS UNCLEAR IF PATIENT HAD HEALED SO THE PATIENT WAS REVISED TO A FEMUR LOCKING PLATE CONSTRUCT. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203021 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER HSB SYNTHES MONUMENT 6694501

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention