BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION TRINION BIODEGRADABLE MENISCUS SCREW

    MDR report key: 1655255 · Received April 7, 2010

    Report

    Report Number
    9710629-2010-00004
    Event Type
    Injury
    Date Received
    April 7, 2010
    Report Date
    April 7, 2010
    Manufacturer
    INION OY
    Product Code
    HWC
    PMA / PMN Number
    K031714
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION, LOT NUMBERS NOT KNOWN. MENISCAL REPAIR IS WELL KNOWN TO BE VERY CHALLENGING AND AS MENTIONED IN THE DISCUSSION SECTION OF THE PAPER OF JARVELA ET AL., ACCORDING TO PREVIOUSLY PUBLISHED LITERATURE (31 REFERENCES) MENISCAL REPAIR FAILURE RATE IS TYPICALLY 0 - 43.5% (ANTICIPATED ADVERSE EVENT). CONSIDERING THIS AND THE FACT THAT 30% OF THE LINVATEC ARROW FIXATIONS FAILED IN THE STUDY OF JARVELA ET AL., THE FAILURE RATE OF INION TRINION SCREWS (17%) CAN ACTUALLY BE CONSIDERED TO BE LOW AND THUS ACCEPTABLE. FURTHERMORE, THE FINDING THAT THE INION TRINION SCREWS DID NOT CAUSE ANY CARTILAGE DAMAGE (AS THE MENISCAL ARROWS TYPICALLY DO, ALSO IN THE STUDY OF JARVELA ET AL.) IS IMPORTANT AND SUPPORTS THE SAFETY OF THE INION TRINION SCREWS IN THIS CHALLENGING INTRA-ARTICULAR APPLICATION. JARVELA ET AL. CONTINUE USING THE INION TRINION MENISCAL SCREWS IN THE TREATMENT OF THEIR MENISCUS PTS. PLEASE SEE THE FOLLOWING STATEMENTS IN THE INSTRUCTIONS FOR USE OF THE INION TRINION SCREWS: "THE PT SHOULD BE WARNED THAT THE FIXATION GIVEN WITH THIS DEVICE CAN BREAK OR LOOSEN AS A RESULT OF EARLY STRESS, ACTIVITY OR LOAD BEARING." "COMPLICATIONS ARE SIMILAR TO THOSE WITH ANY METHOD OF INTERNAL FIXATION." THE INFORMATION IS TAKEN FROM A PUBLISHED CLINICAL STUDY: "ARTHROSCOPIC REPAIR OF MENISCAL RUPTURES. A PROSPECTIVE, RANDOMIZED CLINICAL STUDY USING BIODEGRADABLE SCREW AND ARROW (SUOMEN ORTOPEDIA JA TRAUMATOLOGIA VOL.32, 3-2009). THE ARTICLE IS AVAILABLE IN FINNISH ONLY WITH AN ENGLISH SYNOPSIS.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION OF JARVELA ET AL.2009, 42 PTS WITH MENISCAL RUPTURES RECEIVED ARTHROSCOPIC MENISCAL REPAIR EITHER BY USING THE BIODEGRADABLE INION TRINION MENISCAL SCREWS (21 PTS, 23 REPAIRS) OR BIODEGRADABLE LINVATEC MENISCAL ARROWS (21 PTS, 23 REPAIRS) FOR THE FIXATION. DURING THE FOLLOW-UP, 11 PTS HAD CLINICALLY AND ARTHROSCOPICALLY CONFIRMED FAILURE OF THE FIXATION (4 IN THE INION TRINION GROUP I.E. 17%; AND 7 IN THE LINVATEC ARROW GROUP I.E. 30%). REOPERATION (ARTHROSCOPIC PARTIAL MENISECTOMY) WAS NEEDED IN THESE FAILURE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION TRINION BIODEGRADABLE MENISCUS SCREW MENISCUS SCREW HWC INION OY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention