BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2102014 · Received May 20, 2011

    Report

    Report Number
    9617083-2011-00008
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: THE POSSIBLE ROOT CAUSE IS THAT THE TUNNEL FOR PASSING THE HAMSTRING GRAFT MAY HAVE BEEN TOO TIGHT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WAS INSERTED INTO THE TIBIAL TUNNEL WITH 23MM DRIVER AND IT STARTED CRACKING ACL. THERE WERE NO ADVERSE CONSEQUENCES TO PT/USER. NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGERY WAS COMPLETED USING ANOTHER BIOSTEON SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0910PH248

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention