BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE NAILING SYSTEM

    MDR report key: 6910021 · Received October 3, 2017

    Report

    Report Number
    9615128-2017-00046
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 6, 2017
    Report Date
    October 3, 2017
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    UDI-DI
    07290109335469
    PMA / PMN Number
    K153536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED DEVICE DID NOT REVEAL A DEVIATION FROM SPECIFICATION THAT MAY HAVE CONTRIBUTED TO THE REPORTED CASE. BIOMECHANICAL TESTS HAVE BEEN PERFORMED TO SIMILAR PRODUCTS. ALL TESTED PRODUCTS SUCCESSFULLY PASSED THE BIOMECHANICAL REQUIREMENTS. IT WAS EMPHASIZE TO THE SURGEON, THE IMPORTANCE OF DRILLING AND TAPPING IN ACCORDANCE WITH THE LAG SCREW LENGTH, AS INSTRUCTED IN THE IFU "PICCOLO COMPOSITE® NAILING SYSTEM - PROXIMAL FEMUR INSTRUCTION FOR USE" 13161_014ROW - REV 08/17.

    Description of Event or Problem · 1

    DURING IMPLANTATION OF A PICCOLO COMPOSITE PROXIMAL FEMUR NAIL IN (B)(6), A LAG SCREW BROKE. IN THE TIME OF THE SCREW INSERTION, THE SURGEON FELT RESISTANCE AND DECIDED TO EXTRACT THE SCREW IN ORDER TO REPEAT THE DRILLING. DURING UNSCREWING, THE DISTAL TIP OF THE SCREW BROKE AND THE SURGEON EXTRACTED THE SCREW LEAVING THE DISTAL END IN SITU. ANOTHER CARBOFIX LAG SCREW WAS INSERTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690367 PICCOLO COMPOSITE NAILING SYSTEM PROXIMAL FEMUR LAG SCREW HSB CARBOFIX ORTHOPEDICS LTD. PPF01109 07290109335469

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR