BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2576146 · Received May 4, 2012

    Report

    Report Number
    9617083-2012-00007
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    April 17, 2012
    Report Date
    May 2, 2012
    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 SURGEON DID NOT USE A TAP OR DILATOR DURING THIS CASE FOR THE ORIGINAL SCREW, WHICH MAY HAVE RESULTED IN EXCESSIVE TORQUE BEING APPLIED, WHICH RESULTED IN SCREW FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSERTION OF FEMORAL ACL SCREW, IT BROKE. SURGERY DETAILS: THE PT HAD GOOD BONE QUALITY. THE TUNNEL WAS 10MM DIAMETER WITH 10MM BONE PLUGS, ANTERO-MEDIAL PORTAL APPROACH. IT WAS A BTB REPAIR. ALL OTHER PIECES WERE RETRIEVED. ANOTHER IDENTICAL SCREW WAS FOUND IN 10 SEC AND WAS USED AFTER USING A TAP. NO ADVERSE CONSEQUENCES WERE REPORTED BY THE USER AND THERE WAS NO DELAY IN SURGERY. NO ADD'L ANAESTHETIC WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0811PH108

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention