BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRYX INTERFERENCE SCREW, 9.0 X 25MM

    MDR report key: 1663580 · Received April 14, 2010

    Report

    Report Number
    9613278-2010-00001
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 19, 2010
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, CONMED LINVATEC HAS NOT RECEIVED THE SCREW FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON RECEIPT OF THIS SCREW AND COMPLETION OF AN INVESTIGATION. THE MANUFACTURER HAS UNDERTAKEN A REVIEW OF THE MANUFACTURING AND LOT RELEASE RECORDS FOR THIS PRODUCT. RESULTS OF THE MECHANICAL PRODUCT RELEASE TESTS (TORSIONAL AND SHEAR STRENGTH) DONE FOR THE FINAL DEVICES IN LOT S0003784 MET MANUFACTURER SPECIFICATIONS. IN ADDITION, DIMENSIONAL MEASUREMENTS TAKEN DURING PRODUCTION MET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING INSERTION OF THIS MATRYX INTERFERENCE SCREW FOR AN ACL PROCEDURE, IT CRACKED WHEN INSERTED ABOUT 50-60% OF THE WAY. THE SURGEON'S ATTEMPT TO BACK OUT THE CRACKED SCREW WITH USE OF THE DRIVER WAS UNSUCCESSFUL. THE SURGEON WAS ABLE TO RETRIEVE ALL PIECES OF THE BROKEN SCREW WITH SOME DIFFICULTY BY USING A DRILL BIT, WHICH RESULTED IN A SURGICAL DELAY OF ABOUT 55 MINUTES. THE PROCEDURE WAS COMPLETED WITH USE OF A COMPETITOR'S DEVICE WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRYX INTERFERENCE SCREW, 9.0 X 25MM SCREW, FIXATION, BONE HWC CONMED LINVATEC BIOMATERIALS LTD. S0003784

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR