BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5881961 · Received August 17, 2016

    Report

    Report Number
    2520274-2016-14108
    Event Type
    Injury
    Date Received
    August 17, 2016
    Report Date
    July 28, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JUBEL ET AL (2005). OUTCOMES AND COMPLICATIONS OF ELASTIC STABLE INTRAMEDULLARY NAILING FOR FOREARM FRACTURES IN CHILDREN. J PEDIATR ORTHOP B (2005) 14:375-380. THIS REPORT IS FOR SYNTHES TITANIUM NAILS, UNKNOWN QUANTITY, UNKNOWN LOT NUMBER. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, JUBEL ET AL (2005). OUTCOMES AND COMPLICATIONS OF ELASTIC STABLE INTRAMEDULLARY NAILING FOR FOREARM FRACTURES IN CHILDREN. J PEDIATR ORTHOP B (2005). GERMANY. THIS PROSPECTIVE STUDY INVESTIGATED MEDIUM-TERM OUTCOMES FOR 51 CHILDREN TREATED FROM 1997 TO 2001 FOR DISPLACED DIAPHYSEAL FOREARM FRACTURES WITH ELASTIC STABLE INTRAMEDULLARY NAILING. FORTY-THREE PATIENTS INCLUDED ACHIEVED EXCELLENT/GOOD FUNCTIONAL RESULTS AT AN AVERAGE FOLLOW-UP OF 38 MONTHS. FOUR PATIENTS REQUIRED OPEN FRACTURE-MANIPULATION AT SURGERY. COMPLICATIONS INCLUDED EIGHT CASES OF SOFT-TISSUE IRRITATION AT NAIL-INSERTION SITE (THREE REQUIRED SHORTENING PROCEDURES), TWO TEMPORARY RADIAL NERVE BRANCH INJURIES, FOUR MINIMAL ROTATIONAL MOBILITY DEFICITS, ONE 108 ELBOW EXTENSION DEFICIT AFTER SPLINTING, AND FIVE SMALL KELOID SCARS. ALL PATIENTS WERE PAIN-FREE, WITHOUT LIMITATIONS IN ACTIVITIES FOR DAILY LIFE OR SPORT/PLAY ACTIVITIES BY 12 MONTHS AFTER HARDWARE REMOVAL. ELASTIC STABLE INTRAMEDULLARY NAILING IS APPROPRIATE THERAPY FOR THESE INJURIES. SI'S INCLUDE: OPEN REDUCTION REQUIRED, LESION OF THE SUPERFICIAL BRANCH OF THE RADIAL NERVE, SOFT-TISSUE IRRITATION BY PROTRUDING NAIL END, SECONDARY SHORTENING OF A NAIL REQUIRED, MOBILITY DEFICITS OF THE ADJACENT JOINTS, ROTATIONAL DEFICITS OF THE FOREARM. THIS IS REPORT #1 OF 1 FOR (B)(4). THIS REPORT IS FOR SYNTHES TITANIUM NAILS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536706 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention