BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNA LOCKING TROCHANTERIC NAIL SYSTEM

    MDR report key: 7800186 · Received August 21, 2018

    Report

    Report Number
    9617297-2018-00008
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 17, 2018
    Manufacturer
    U&I CORPORATION
    Product Code
    HSB
    UDI-DI
    08800015916509
    PMA / PMN Number
    K093707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE BROKEN TROCHANTERIC NAIL IS UNKNOWN. THE TROCHANTERIC NAIL BROKE INTO TWO PIECES. ONE WAS DISCARDED BY NURSE. THEREFORE, WE ARE UNABLE TO REVIEW DEVICE HISTORY RECORDS AND CHECK FUNCTION OR DIMENSIONS. WHEN WE SURVEY THE INCIDENCE OF BREAKAGE OF ANOTHER COMPANY PRODUCTS THROUGH THE ASSOCIATED PAPER, THE INCIDENCE OF BREAKAGE RANGES BETWEEN 0.2% AND 5.7%. THE INCIDENCE OF BREAKAGE OF OUR PRODUCT IS (B)(4) AND LOWER THAN THEM.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). A PATIENT UNDERWENT SURGERY ON (B)(6) 2018. A 130-11X200MM TROCHANTERIC NAIL WAS BROKEN IN PATIENT POSTOPERATIVELY. THE BROKEN TROCHANTERIC NAIL WAS REMOVED AND REPLACED WITH ANOTHER PRODUCTS ON (B)(6) 2018. IT WAS REPORTED THAT AFTER REVISION SURGERY, THE PATIENT LEFT THE HOSPITAL AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644370 DYNA LOCKING TROCHANTERIC NAIL SYSTEM INTRAMEDULLARY FIXATION ROD HSB U&I CORPORATION 08800015916509

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention