BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX

    MDR report key: 8833389 · Received July 26, 2019

    Report

    Report Number
    1221934-2019-57820
    Event Type
    Injury
    Date Received
    July 26, 2019
    Report Date
    July 5, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN BIO-INTRAFIX. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN RIGIDFIX CROSS PIN. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HEE-GON PARK ET AL, 2013, " INFLUENCE OF POSTERIOR TIBIAL SLOPE ON STABILITY AND SECOND-LOOK ARTHROSCOPIC FINDINGS AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION", THE JOURNAL OF THE KOREAN ORTHOPAEDIC ASSOCIATION VOLUME 48 NUMBER 4 PAGE NO 266-272, SOUTH KOREA. THE STUDY EMPHASIZES ON ANALYZING THE INFLUENCE OF POSTERIOR TIBIAL SLOPE ON STABILITY IN CLINICAL AND SECOND-LOOK ARTHROSCOPIC EVALUATION AFTER ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: THIS IS A RETROSPECTIVE STUDY ANALYZING 124 PATIENTS FROM JANUARY 2000 TO MARCH 2011 WITH MEAN AGE 31.8 YEARS OLD (104 MALES AND 20 FEMALES). THE PATIENT UNDERWENT ACL RECONSTRUCTION USING TIBIALIS ANTERIOR ALLOGRAFT (57 CASES) AND ACHILLES TENDON (67 CASES) AND WERE ABLE TO BE FOLLOWED FOR AT LEAST ONE YEAR. BODY MASS INDEX WAS 24.6 KG/M2 (17.7¿39.1), AND ACL RECONSTRUCTION WAS PERFORMED IN ALL CASES WITHIN THREE WEEKS AFTER INJURY. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ACL RECONSTRUCTION USING TIBIALIS ANTERIOR ALLOGRAFT OR ACHILLES TENDON THE AVERAGE FOLLOW-UP PERIOD WAS 24.4 MONTHS (12¿49 MONTHS), AND SECOND-LOOK ARTHROSCOPY WAS PERFORMED AT AN AVERAGE 13.2 MONTHS (9¿42MONTHS) AFTER THE OPERATION. THE DEVICES INVOLVED WERE: RIGIDFIX CROSS PIN WAS USED FOR FEMORAL FIXATION. DEPUY MITEK INTRAFIX SYSTEM, LIGAMENT ANCHOR SCREWS INCLUDING WASHER AND TENSIONER WAS USED FOR TIBIAL SIDE. COMPLICATIONS MENTIONED IN THE ARTICLE WERE: CYCLOPS LESIONS AND PARTIAL RUPTURE OF THE GRAFT WAS REPORTED IN THE ARTICLE. THE CONCLUSION FROM THE REVIEW OF THIS ARTICLE IS THAT MITEK DEVICES CANNOT BE DISASSOCIATED WITH COMPLICATION (PARTIAL RUPTURE) NOTED IN THE ARTICLE. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623882 UNKNOWN BIO-INTRAFIX SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention