BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 4379716 · Received December 22, 2014

    Report

    Report Number
    9617083-2014-00042
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 19, 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, POSSIBLE SUSPECTED ROOT CAUSE(S): THE MOST LIKELY CAUSE OF FAILURE IS TO TIGHT A BONE TUNNEL. THIS RESULTS IN EXCESSIVE TORQUE BEING REQUIRED TO INSERT THE SCREW, WHICH CAUSES FLATTENING OF THE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BIOSTEON SCREW DID NOT GRIP IN THE TIBIAL DRILLING CANAL. (THREAD DAMAGE). SURGERY WAS COMPLETED SUCCESSFUL USING ANOTHER BIOSTEON SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843375 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0614PH125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention