BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 3952131 · Received May 9, 2014

    Report

    Report Number
    9617083-2014-00017
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE AND FROM VISUAL EXAMINATION OF THE RETURNED DEVICE, POSSIBLE SUSPECTED ROOT CAUSE IS ROTATION OF THE SCREW/DRIVER WHILE THE SCREW FAILED TO ADVANCE FURTHER INTO THE TUNNEL, RESULTING IN SHEAR FAILURE OF THE SCREW, PARTICULARLY IF THE DRIVER WAS NOT FULLY ENGAGED. IN ADDITION, INSERTION OVER A BENT GUIDEWIRE WOULD PREVENT THE SCREW FROM ADVANCING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, THE SCREW BROKE INSIDE THE TIBIAL DRILLING CHANNEL DURING INSERTION. A PIECE OF THE SCREW STILL REMAINS IN THE PATIENT - THE SURGEON PLACED A SMALL SCREW IN ADDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282255 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0513PH135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention