BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON INTERFERENCE SCREW

    MDR report key: 1719558 · Received April 29, 2010

    Report

    Report Number
    9617083-2010-00001
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    March 11, 2010
    Report Date
    April 29, 2010
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    HWC
    PMA / PMN Number
    K003641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH MANUFACTURING RECORD REVIEW AND NO MANUFACTURING PROBLEMS IDENTIFIED. SUSPECTED ROOT CAUSES: USE OF DAMAGED OR BENT DRIVER. FAILURE TO FULLY AND ACCURATELY ENGAGE THE DRIVER. POOR DRIVER FIT. FAILURE TO TAP IF BONE PATELLAR TENDON BONE GRAFT USED GRAFT/SCREW/TUNNEL NOT APPROPRIATELY SIZED. HARD, DENSE BONE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCREW BROKE DURING SCREWING IN, DURING SURGERY. AS PER CUSTOMER UPDATE REC'D ON (B)(6) , 2010, THE SCREW BROKE IN 3 PARTS DURING SCREWING IN THE FEMORAL CANAL USING THE GUIDE WIRE. AS CUSTOMER INFORMED THE EVENT RESULTED IN THE NEED OF REMOVING THE ELEMENTS OF THE SCREW FROM THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSTEON INTERFERENCE SCREW BONE SCREW HWC BIOCOMPOSITES LTD. 0508PH244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention