BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 2492806 · Received February 14, 2012

    Report

    Report Number
    9617083-2012-00002
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    December 7, 2011
    Report Date
    February 13, 2012
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K0003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSE: DRIVER NOT FULLY ENGAGED CAUSING THE ROOT THREAD TO "UNWIND" AND BREAK AT THE TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BROKE DURING SURGERY. ANOTHER SCREW WAS USED. NO ADVERSE CONSEQUENCES REPORTED BY THE USER. THE PATIENT WAS MALE, (B)(6), GOOD BONE QUALITY. TREATMENT ACL. INITIAL CONDITION WAS ACL RUPTURE. FEMORAL TUNNEL 9MM DIAMETER, LENGTH 30MM. TIBIAL TUNNEL DIAMETER OF 10MM. THE SCREW WAS BEING INSERTED INTO THE FEMORAL TUNNEL, TUNNEL 9MM. THE GRAFT WAS 10.5 CM LONG, [CHEWING BONE FEMORAL AND TIBIAL 25MM 30MM]. THE SURGEON USED A DILATOR SIZE 8X22, 5MM IN THE FEMUR. IT WAS ANTEROMEDIAL APPROACH. SCREW DEBRIS LEFT INSIDE JOINT. SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT. TOOK 5 MINUTES TO FIND REPLACEMENT AND THERE WAS A 30 MINUTE DELAY IN SURGERY. ADDITIONAL ANESTHETIC WAS PROVIDED TO THE PATIENT FOR 30 MINUTES LONGER. THE SCREW WAS RETURNED TO BIOCOMPOSITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON WEDGE INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0711PH137

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention