BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 3955749 · Received February 6, 2014

    Report

    Report Number
    9617083-2013-00024
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 11, 2013
    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

    DELAY IS SENDING THE 30 DAY MFR REPORT DUE TO ADMIN OVERSIGHT. SUSPECTED ROOT CAUSE: FROM VISUAL EXAMINATION OF THE SCREW AND BASED ON THE INFO RECEIVED, POSSIBLE SUSPECTED ROOT CAUSE IS THAT THE BONE TUNNEL WAS TOO TIGHT. THIS RESULTS IN EXCESSIVE FLATTENING OF THE SCREW THREADS AND SHEARING-OFF OF THE DISTAL TIP OF THE SCREW. IN ADDITION TO THE POSSIBILITY THAT THE SCREW WAS TOO LARGE TO ENGAGE INTO THE BONE TUNNEL, IT COULD ALSO BE THAT THE SCREW WAS NOT FULLY ENGAGED ON THE DRIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, THE SCREW TIP HAD BROKEN OFF DURING INSERTION. THERE WAS A DELAY OF 2 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78984 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0413PH263

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention