BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI CANNULATED HUMERAL NAIL-EX/250MM-STERILE

    MDR report key: 2221546 · Received August 18, 2011

    Report

    Report Number
    1719045-2011-00556
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K033071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A LEFT HUMERUS EX NAIL PROCEDURE, THE CANNULATED HUMERAL EX-NAIL WAS INSERTED SUCCESSFULLY. SURGEON WAS THEN INSERTING THE MOST PROXIMAL SCREW OF THE THREE DISTAL SCREWS, AND PERFORATED THE BRACHIAL ARTERY. A VASCULAR SURGEON WAS CALLED IN OPERATING ROOM FOR THE REPAIR OF THE ARTERY, SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. IT WAS NOTED PT OUTCOME WAS OK. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9MM TI CANNULATED HUMERAL NAIL-EX/250MM-STERILE TI CANNULATED HUMERAL NAIL-EX JDS SYNTHES MONUMENT 6449551

    Patients

    Seq Age Sex Outcome Treatment
    1 DISTAL SCREW