BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2439311 · Received January 31, 2012

    Report

    Report Number
    9617083-2012-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    November 28, 2011
    Report Date
    January 30, 2012
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: USE OF DAMAGED OR BENT DRIVER. USING AN OLDER 7 MM TAP RATHER THAN A NEWER BIOSTEON TAP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE SURGEON WAS IMPLANTING FEMORAL SCREW DURING ACL PROCEDURE, BTB GRAFT. THE SURGEON USES TRADITIONAL TRANSTIBIAL APPROACH WITH A BONE TENDON BONE GRAFT. HE REAMED HIS TUNNEL TO 9 MM AS WELL AS USING STRYKER TAPS TO START THE SCREW. AFTER TAPPING, THE SURGEON PROCEEDED TO IMPLANT THE 7 MM SCREW. AFTER IMPLANTING THE SCREW, THE SURGEON REALIZED THAT THE SCREWDRIVER HAD BENT/TWISTED. THE CASE WAS NOT DELAYED AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE OR ADVERSE CONSEQUENCES FOR THE PT. ON (B)(6) 2011, IT WAS ALSO REPORTED THAT THE SCREW IMPLANTED DURING THIS EVENT CRACKED. THE SCREW IS IMPLANTED AND HENCE IS NOT AVAILABLE FOR RETURN. THE 23/28/35MM BIOSTEON SCREW DRIVER WAS ONLY A FEW MONTHS OLD AND ONLY USED PROBABLY AROUND 10 OR SO TIMES. THE DRIVER TWISTED DURING INSERTION OF THE FEMORAL SCREW. IT WAS NOTICED THAT THE DRIVER BENT WHEN THE SURGEON WENT TO INSERT THE TIBIAL SCREW. THE SURGEON DID NOT USE EXCESSIVE FORCE AND THE CASE WAS NOT ANY MORE DIFFICULT THAN THE NORMAL BTB ACL CASE UNDERTAKEN. BY THE SURGEON. STRYKER HAVE, HOWEVER, CONFIRMED THAT AN OLDER 7MM TAP WAS USED, NOT ONE OF THE NEW BIOSTEON TAPS, WHICH WERE LAUNCHED IN 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. NOT CONFIRMED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention