BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2489615 · Received March 8, 2012

    Report

    Report Number
    9617083-2012-00006
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    January 25, 2012
    Report Date
    March 1, 2012
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: THE DIAMETER TUNNEL IS POSSIBLY TOO LARGE. THE INFO PROVIDED SEEMS TO SUGGEST THAT THE ROOT CAUSE IS POSSIBLY A LOOSE FIT IN THE TRANSVERSE DRILL HOLE. THIS WOULD FACILITATE 'TOGGLING', HENCE THE PROXIMAL END WOULD HAVE THE SCOPE FOR MORE MOVEMENT DURING INSERTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTION OF THE CROSS-PIN, THE SURGEON REMOVED THE INSERTER AND THE PIN WAS BROKEN. IT WAS REPORTED THAT HALF OF THE PIN REMAINS IN THE PT AND THAT THE SURGEON IS CONCERNED ABOUT FIXATION. PT HAS NORMAL BONE QUALITY. THE SURGEON HAS USED THE CROSS PIN APPROXIMATELY 30 TIMES PER YEAR FOR 7 YEARS. ALL THE PROPER INSTRUMENTATION WAS USED. THE APPROPRIATE CROSS PIN ACL INSTRUMENTATION WAS USED TO DRILL THE FEMORAL TUNNEL, TRANSTIB TECHNIQUE. THE CORRECT TEMP AND FLUTED REAMER WAS USED. A BIOSTEON INSERTION PIN WAS USED AND THE GUIDE PINS WERE NOT BENT. THERE WERE NO ISSUES IN SLIDING THE BIOSTEON INSERTION PIN INTO THE JOINT AND THE TUNNEL AND GRAFT DIAMETERS WERE BOTH 7MM. THE GRAFT WAS SECURE. NO BACK UP SCREW WAS IN THE FEMORAL TUNNEL TO ENSURE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0911PH178

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention