BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNA LOCKING TROCHANTERIC NAIL

    MDR report key: 10639771 · Received October 6, 2020

    Report

    Report Number
    9617297-2020-00006
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 7, 2020
    Manufacturer
    U&I CORPORATION
    Product Code
    HSB
    UDI-DI
    08800015918060
    PMA / PMN Number
    K093707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHENOMENON ANALYSIS: CUT-OUT IS GENERALLY WELL-KNOWN AS THE PROBLEM WHICH COULD BE POSSIBLY HAPPENED AFTER OPERATING THE SURGERY USING FEMORAL NAIL TO PATIENTS ROUGHLY AGED OVER 70 CONSIDERING THE BONE DENSITY IS GETTING LOWER AS PER AGING. ACCORDING TO THE LITERATURE REVIEW, THE INCIDENT RATE OF CUT-OUT IS AVERAGE ON 3.0%(0%~14.9%). (REVIEWED LITERATURES ARE ATTACHED IN THIS REPORT.) WEDGE WING, THE COMPONENT WHICH WOULD HELP THE NECK SCREW NOT TO BE MIGRATED WAS NOT USED IN THE SURGERY. AND BY OBSERVING SOME SCRATCHES ON RETURNED PRODUCT AS WELL AS THE X-RAY PICTURE SHOWING NECK SCREW IS CONSIDERABLY MIGRATED, IT IS ASSUMED THAT THE FIXED NAIL CAP WAS NOT OPTIMALLY PLACED TO THE NECK SCREW, FOLLOWED BY THE MIGRATION AS MICRO-MOTION WAS GENERATED BY THE PATIENT IN HIS DAILY LIFE. RECORDS REVIEW: PATIENT IS A KOREAN AND THIS INCIDENT HAPPENED IN KOREA. WE HAVE REVIEWED THE DEVICE HISTORY RECORD (MANUFACTURING & INSPECTION ) OF THE RELEVANT PRODUCTS, HOWEVER, WE CANNOT FIND ANY QUALITY PROBLEM IN THOSE RECORDS. PROGRESS ON THE PATIENT: ON (B)(6) 2020, THE PATIENT GOT TOTAL HIP REPLACEMENT SURGERY ON THE SAME AREA AS ADDITIONAL SURGERY AFTER EXPLANTING THE IMPLANTS. THE PATIENT'S CONDITION IS GOING TO BE CONSISTENTLY MONITORED.

    Description of Event or Problem · 1

    AFTER UNDERGOING TROCHANTERIC NAIL INSERTION SURGERY ON (B)(6) 2020, THE PATIENT STARTED TO FEEL PAIN IN THE SURGERY AREA. SUBSEQUENTLY THE PATIENT VISITED THE HOSPITAL ON (B)(6) 2020 AND IT WAS CONFIRMED THAT CUT-OUT WAS OBSERVED AS THE NECK SCREW ENTERED ACETABULUM. THE RELEVANT IMPLANTS WERE REMOVED ON (B)(6) 2020 THEN TOTAL HIP REPLACEMENT WAS PERFORMED ON THE PATIENT IN THE OTHER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097729 DYNA LOCKING TROCHANTERIC NAIL INTRAMEDULLARY FIXATION ROD HSB U&I CORPORATION NGA2100 19I23007 08800015918060

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other