BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNA LOCKING TROCHANTERIC NAIL

    MDR report key: 9400194 · Received December 3, 2019

    Report

    Report Number
    9617297-2019-00005
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 8, 2019
    Report Date
    December 3, 2019
    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

    WE ASKED THE HOSPITAL AND THE DISTRIBUTOR FOR MORE INFORMATION ABOUT THE PATIENT REGARDING THE CUSTOMER COMPLAINT, BUT WERE UNABLE TO OBTAIN ANY INFORMATION OTHER THAN AGE AND GENDER. REANALYSIS OF THE CHEMICALS AND MECHANICAL PROPERTIES, DIMENSIONS AND APPEARANCE OF THE DAMAGED PRODUCT FOUND THEM TO BE WITHIN ACCEPTABLE CRITERIA, AND THE ENTIRE PRODUCTION AND INSPECTION RECORDS SHOWED NO ABNORMALITIES. IT SEEMS THAT THE REASON WHY IMPLANT WAS DAMAGED IN 10 MONTHS AFTER SURGERY ON DECEMBER 20, 2018 IS BECAUSE OF VARIOUS FACTORS SUCH AS PATIENT AGE, HISTORY (E.G. OSTEOPOROSIS), AND ACTIVITY. IN A RELATED PAPER*, WE FOUND THAT THE RATE OF BREAKAGE OF OTHER COMPANIES' PRODUCTS WAS BETWEEN 0.2% AND 5.7%, HIGHER THAN THE RATE OF BREAKAGE OF OUR PRODUCTS, 0.04%. BREAKAGE OF A THIRD GENERATION GAMMA NAIL: A CASE REPORT AND REVIEW OF THE LITERATURE.

    Description of Event or Problem · 1

    THIS EVENT OCCURED IN SOUTH KOREA. THE FEMALE PATIENT UNDERWENT SURGERY FOR IMPLANTING DYNA LOCKING TROCHANTERIC NAIL SYSTEM ON (B)(6) 2018. IT IS CONFIRMED THAT THE TROCHANTERIC NAIL 130-11X200MM(NG1120) HAS BEEN BROKEN IN THE PATIENT BODY POSTOPERATIVELY AFTER AROUND 10 MONTHS ((B)(6) 2019) AND THE REVISION SURGERY WAS CONDUCTED FOR REMOVING THE NAIL ((B)(6) 2019).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201047 DYNA LOCKING TROCHANTERIC NAIL INTRAMEDULLARY FIXATION ROD HSB U&I CORPORATION NG1120 18I282-1 08800015916509

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention