BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNA LOCKING TROCHANTERIC NAIL

    MDR report key: 17339949 · Received July 18, 2023

    Report

    Report Number
    9617297-2023-00001
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 2, 2023
    Report Date
    July 17, 2023
    Manufacturer
    INNOSYS CO., LTD.
    Product Code
    HSB
    UDI-DI
    08800015916974
    PMA / PMN Number
    K093707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: UPON REVIEWING THE PRODUCTION AND INSPECTION RECORDS OF THE FRACTURED TROCHANTERIC NAIL, IT WAS CONFIRMED THAT IT WAS MANUFACTURED PROPERLY. UPON EXAMINATION OF THE RETRIEVED NAIL, IT WAS OBSERVED THAT THE INSIDE OF THE NAIL HOLE WAS DEEPLY INDENTED, LIKELY DUE TO THE NECK SCREW. THIS SUGGESTS THAT THE FRACTURE OCCURRED DUE TO PATIENT-RELATED FACTORS. THE PROBABLE CAUSE OF THIS PROBLEM (EARLY FRACTURE OF IMPLANT) IS ATTRIBUTED TO THE WEIGHT-BEARING (E.G., WALKING PRACTICE SHORTLY AFTER SURGERY) OR EXTERNAL IMPACT (E.G., A FALL) ON THE IMPLANT BY THE ELDERLY PATIENT BEFORE COMPLETE BONE UNION. BASED ON THE LITERATURE REVIEW, AFTER FEMORAL BONE FRACTURE TREATMENT, IT IS RECOMMENDED TO ALLOW JOINT MOVEMENT WITHOUT WEIGHT-BEARING FOR UP TO 7 DAYS, AND PARTIAL WEIGHT-BEARING WALKING EXERCIESS WITH CRUTCHES OR A WALKING AID CAN START FROM 10 DAYS (STABLE FRACTURES) TO 3 WEEKS (UNSTABLE FRACTURES) AFTER THE SURGERY. (S.S KIM, HIP PELVIS 25(3)2013) FURTHERMORE, RESTRICTING WEIGHT-BEARING AFTER SURGERY HAS BEEN FOUND TO REDUCE POTENTIAL COMPLICATIONS IN ELDERLY PATIENTS. (C GUNAY, ACTA ORTHOP. BELG., 80, 2014). ADDITIONALLY, PHYSICAL DAMAGE (SCRATCHES) FROM THE SURGICAL PROCEDURE (REAMING) WAS OBSERVED ON THE EXTERIOR OF THE NAIL. SUCH DAMAGE CAN ACT AS A STRESS-RISING FACTOR. CURRENT STATUS: WE HAVE PROVIDED FEEDBACK TO THE USER BASED ON THE INVESTIGATION JULY 12, 2023. AND AFTER CONFIRMING THE FRACTURE OF THE NAIL, THE FRACTURED IMPLANT WAS REMOVED AND A REOPERATION WAS SUCCESSFULLY COMPLETED ON (B)(6) 2023. AS OF NOW, THERE ARE NO SPECIFIC HEALTH ISSUES IDENTIFIED AND WE WILL CONTINUE TO MONITOR THE PATIENT'S HEALTH CONDITION.

    Description of Event or Problem · 0

    THIS ISSUE OCCURRED IN KOREA. ON (B)(6) 2023 THE PATIENT HAD A SURGERY TO IMPLANT THE DYNA LOCKING TROCHANTERIC NAIL SYSTEM. THE FRACTURE OF THE TROCHANTERIC NAIL 130-12X200MM WAS CONFIRMED THROUGH AN X-RAY REVIEW CONDUCTED 7 DAYS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169831 DYNA LOCKING TROCHANTERIC NAIL INTRAMEDULLARY FIXATION ROD HSB INNOSYS CO., LTD. NG1220 18H217 08800015916974

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Other