BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERONAIL

    MDR report key: 1285923 · Received November 5, 2008

    Report

    Report Number
    9680825-2008-00009
    Event Type
    Other
    Date Received
    November 5, 2008
    Date of Event
    July 16, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THIS EVENT DOES NOT MEET THE FDA REQUIREMENTS OF MANDATORY REPORTING, AFTER SPEAKING WITH FDA AND IN KEEPING WITH THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON JANUARY 15, 2008, ORTHOFIX SRL HAS DECIDED TO REPORT THIS TYPE OF EVENT ON A VOLUNTARY BASE. THE DEVICE WAS RETURNED TO ORTHOFIX ON SEPTEMBER 10, 2008 AND WAS EXAMINED BY THE ORTHOFIX ENGINEERING DEPARTMENT. IT WAS IMMEDIATELY SENT ON TO AN EXTERNAL LABORATORY FOR CHEMICAL, MECHANICAL, METALLURGICAL AND FAILURE ANALYSIS. THE CONCLUSION OF THE LABORATORY IS THAT THE MATERIAL CONFIRMS TO ORTHOFIX SPECIFICATIONS. THE BROKEN WIRE DID NOT SHOW ANOMALIES OR DEFECTS THAT COULD LIMIT ITS SERVICE PERFORMANCE. THE BREAKAGE OF THE WIRE WAS DUE TO A TORSIONAL OVERLOAD, AS EVIDENCED BY THE SHAPE AND MORPHOLOGY OF THE FRACTURE. ORTHOFIX SURMISES THE WIRE WAS MOST LIKELY SUBJECTED TO ONE OR MORE OVERLOADS DURING THE INSERTION PROCESS. ORTHOFIX CONTINUES TO MONITOR THE PRODUCT LINE IN THE MARKET AND SHOULD ADDITIONAL INFORMATION COME TO LIGHT, ORTHOFIX WILL FINALIZE THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING INSERTION OF THE DEVICE FOR SURGICAL REPAIR OF A FRACTURED FEMUR, THE WIRE BROKE ACROSS THE THREADED TRACT AND THE TIP OF THE BROKEN WIRE REMAINS IN THE PATIENT'S LEFT FEMUR. THE SURGICAL PROCESS NEEDED TO BE PROLONGED AND ANOTHER DEVICE WAS PLACED. ORTHOFIX WAS FIRST NOTIFIED OF THIS EVENT ON (B) (6), 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERONAIL THREADED WIRE D.3X400MM JDS ORTHOFIX SRL 173288 G003

    Patients

    Seq Age Sex Outcome Treatment
    1