BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 7359576 · Received March 21, 2018

    Report

    Report Number
    3025141-2018-00141
    Event Type
    Injury
    Date Received
    March 21, 2018
    Report Date
    March 7, 2018
    Manufacturer
    ACUMED LLC
    Product Code
    HSB
    PMA / PMN Number
    K915613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER ATTACHED ARTICLE, AN ACUMED IM FOREARM ROD WAS IMPLANTED IN A (B)(6) MALE AFTER HIS ARM WAS CAUGHT IN A CONVEYOR BELT. NINETEEN MONTHS LATER AN ATTEMPT WAS MADE TO REMOVE THE IMPLANT, IT FAILED BECAUSE THE THREADED PORTION OF THE NAIL REMOVER WAS BROKEN WHILE BEING CONNECTED TO THE NAIL. TWO YEARS AFTER THE FAILED SURGERY, THE PATIENT VISITED WITH COMPLAINTS OF OCCURRENCE OF LEFT ELBOW PAIN, WITHOUT HAVING ANY NEW TRAUMA. A PARTIAL DEFECT OF THE TRICEPS TENDON WITH SEVERE PAIN AND TENDERNESS AROUND THE SCAR OF NAIL INSERTION WAS NOTED. NO OTHER ABNORMALITIES WERE OBSERVED. ULTRASONOGRAPHY REVEALED PARTIAL RUPTURE OF THE TRICEPS TENDON, AND BURSITIS AROUND THE TENDER AREA. BASED ON THESE OBSERVATIONS, THE NAIL WAS REMOVED AND REPAIR OF THE TENDON WAS DONE. REFERENCE: NEW TECHNIQUE FOR REMOVAL OF THE ULNAR INTRAMEDULLARY NAIL FAILED TO REMOVE: BROKEN ASSEMBLY PIECE IN THE NAIL. JIN WOONG YI, BYUNG HAK OH, SANG-BUM KIM, YOUN MOO HEO, TAE GYUN KIM, DOO HYUN KIM, YOU SUN JUNG. CLINICS IN ORTHOPEDIC SURGERY. 2016; 8:210-213.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202350 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention