BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2890814 · Received November 15, 2012

    Report

    Report Number
    9617083-2012-00032
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 2, 2012
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: FROM VISUAL EXAMINATION OF THE DEVICE, THE SCREW HAD FRACTURED CIRCUMFERENTIALLY, IN TORSION, AT A POSITION APPROXIMATELY 6MM PROXIMAL TO THE TIP OF THE ENGAGED DRIVER. THIS OCCURS WHEN RESISTANCE TO INSERTION IS HIGH AND THE APPLIED TORQUE EXCEEDS THE TORSIONAL STRENGTH OF THE SCREW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SURGERY PERFORMED ON A MALE PATIENT, TWO SCREWS BROKE. THE FIRST SCREW WAS BEING SCREWED INTO THE BONE AND SUDDENLY BROKE. THE TUNNEL HAD BEEN PREPARED BEFORE THE SURGEON HAD ATTEMPTED TO IMPLANT THE SCREW. THE SECOND SCREW ALSO BROKE. A TITANIUM SCREW WAS USED TO ORDER IN COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES. THIS REPORT IS IN ASSOCIATION WITH THE SECOND SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0212PH311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention