BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRYX INTERFERENCE SCREW

    MDR report key: 1242922 · Received November 20, 2008

    Report

    Report Number
    9613278-2008-00010
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD
    Product Code
    MAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS UNDERTAKEN A REVIEW OF MFG AND COMPLAINT HISTORY RECORDS FOR THIS LOT. THE MFG RECORDS FOR LOT S0003506 WERE FOUND TO BE IN COMPLIANCE WITH THE REQUIREMENTS. TORSIONAL AND SHEAR STRENGTH VALUES OF THE FINAL DEVICES FROM THIS LOT WERE WELL ABOVE THE MINIMUM ACCEPTANCE LIMITS. THIS IS THE ONLY COMPLAINT RECEIVED FOR LOT S0003506.

    Description of Event or Problem · 1

    WHILE INSERTING AN 8 MM SCREW INTO 8 MM TUNNEL ON TIBIAL SIDE, MATRYX SCREW BROKE INTO 8 PIECES. DR. WAS ONLY ABLE TO RETRIEVE 1 LARGE PIECE AND LEFT THE OTHER IN PT. PROCEDURE WAS COMPLETED WITH AN ARTHREX BONE STAPLER. NO INJURIES WERE REPORTED, ONLY MINOR SURGICAL DELAY. WE DECIDED TO REPORT THIS CASE, BECAUSE DR. WAS NOT ABLE TO RETRIEVE ALL THE PIECES OF THE MATRYX INTERFERENCE SCREW. MATRYX INTERFERENCE SCREW IS A COMPOSITE MADE OF POLYLACTIDE COPOLYMER (PLA COP) AND B-TRICALCIUM PHOSPHATE (TCP) AND THUS THE REMAINING PIECES WILL DEGRADE INTO A BODY AND SHOULD NOT CAUSE ANY ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRYX INTERFERENCE SCREW BIOABSORBABLE BONE FIXATION DEVICE MAI CONMED LINVATEC BIOMATERIALS LTD S0003506

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other