BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOFIX

    MDR report key: 473608 · Received July 11, 2003

    Report

    Report Number
    MW1029051
    Event Type
    Injury
    Date Received
    July 11, 2003
    Date of Event
    June 25, 2003
    Report Date
    July 9, 2003
    Manufacturer
    ORTHOFIX INC.
    Product Code
    JDW
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A POTENTIAL FOR MAJOR BREAK IN STERILE TECHNIQUE IDENTIFIED. THE STERILE PACKAGING SYSTEM FOR THE ORTHOFIX BONE SCREWS ARE EXTREMELY MISLEADING. THE SCREW IS PACKAGED IN A DOUBLE PEEL POUCH AND HOUSED INSIDE A PLASTIC TUBE. THE PLASTIC TUBE HAS AN INNER TUBE THAT TWISTS OUT OF THE OUTER TUBE. THE OUTSIDE OF THE CONTAINER IS LABELED CLEARLY "STERILE" CONTENTS STERILE. IN FACT, THE DOUBLE PEEL POUCH INSIDE THE TUBE IS NOT STERILE, ONLY THE SECOND INSIDE PEEL POUCH IS STERILE. THE CO WAS NOTIFIED OF THE MISLEADING LABEL AND IS "PHASING OUT" THIS TYPE OF PACKAGING SYSTEM. BUT, THEY COULD NOT GUARANTEE THAT REPLACEMENT ORDERS WOULD CONTAIN THE NEW IMPROVED PACKAGING. THIS IS POTENTIALLY DANGEROUS FOR PTS IF A BREAK IN TECHNIQUE OCCURRED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/09/03: MFR HAS NO RECORD OF ANY EVENT OCCURRING ON EVENT DATE OR ANY OTHER DATE DURING THE PERIOD ( 1 JANUARY 1995-PRESENT) OTHER THAN THE ONE THAT OCCURRED IN NOVEMBER 2001. THERE HAVE BEEN NO ACTIONS TAKEN AS A RESULT OF THIS REPORTED INCIDENT AS THE ANALYSES CONFIRMED THAT THE SCREWS HAD BEEN PACKAGED IN DOUBLE POUCHES. THE INSTITUTION WHERE THE INCIDENT OCCURRED WAS NOTIFIED OF THE ANALYTICAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOFIX BONE SCREW CONTAINER (PLASTIC TUBE) JDW ORTHOFIX INC. 150/30MM SCREW 09D01

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention