BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2823753 · Received October 10, 2012

    Report

    Report Number
    9617083-2012-00027
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 8, 2012
    Report Date
    October 8, 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: ATTEMPTED INSERTION OF THE SCREW INTO A TUNNEL TOO SMALL/TIGHT FOR THE DIAMETER OF SCREW. AS A RESULT, THE EXCESSIVE TORQUE APPLIED TO THE DRIVER HAS RESULTED IN TO TIP OF THE SCREW BREAKING OFF. A PARTICULARLY HARD/DENSE BONE COULD BE A CONTRIBUTORY FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCEDURE OF SCREWING THE SCREW INTO THE PREPARED TUNNEL, IT'S HEAD DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0212PH191

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention