BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX

    MDR report key: 8833173 · Received July 26, 2019

    Report

    Report Number
    1221934-2019-57815
    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

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: 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. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN RIGIDFIX CROSS PIN. (B)(4). DEVICE EVALUATED BY MFR, MANUFACTURE DATE: 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: JU-HONG LEE ET AL, 2011, "COMPARISON OF TUNNEL ENLARGEMENT BETWEEN SINGLE- AND DOUBLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION" THE JOURNAL OF THE KOREAN ORTHOPAEDIC ASSOCIATION VOLUME 46 NUMBER 4, PAGE NO: 312-319, SOUTH KOREA. THE STUDY EMPHASIZES ON THE COMPARISON OF THE DEGREE OF TUNNEL ENLARGEMENT IN PATIENTS WHO HAD UNDERGONE A DOUBLE-BUNDLE (DB) OR SINGLE-BUNDLE (SB) ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION AND TO FIND THE CORRELATION BETWEEN THE TUNNEL ENLARGEMENT AND THE CLINICAL RESULTS. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: FROM JANUARY 2004 TO MAY 2008, 38 PATIENTS WHO UNDERWENT A SB-ACL (MEAN AGE 20 YEARS) RECONSTRUCTION AND 30 PATIENTS WHO UNDERWENT A DB-ACL (MEAN AGE 33.75 YEARS) RECONSTRUCTION WERE EXAMINED. THE EVALUATION METHODS WERE THE LACHMAN TEST, PIVOT-SHIFT TEST, KT-1000 MEASUREMENT FOR KNEE STABILITY, LYSHOLM SCORE, AND INTERNATIONAL KNEE DOCUMENTATION COMMITTEE (IKDC) RATINGS FOR FUNCTIONAL RESULTS. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: SINGLE BUNDLE ACL RECONSTRUCTION USING AN AUTOGENOUS HAMSTRING TENDON AND A TRANSTIBIAL TECHNIQUE AND DOUBLE BUNDLE RECONSTRUCTION BY USING SEMITENDINOSUS GRAFT AND YASUDA TECHNIQUE OF TIBIAL AND FEMORAL TUNNEL PERFORATION. THEY WERE FOLLOWED FOR ONE YEAR. THE AVERAGE FOLLOW-UP PERIOD WAS 28.3 MONTHS (RANGE: 12¿58) FOR SINGLE-BUNDLE RECONSTRUCTION AND 18.7 MONTHS FOR DOUBLE-BUNDLE RECONSTRUCTION (RANGE: 12¿33). THE DEVICES INVOLVED WERE: IN ALL THE CASES , THE FEMORAL FIXATION OF THE GRAFT WAS PERFORMED WITH RIGID FIX SYSTEMTM AND THE TIBIA WAS FIXED WITH INTRAFIXTM ON THE KNEE FLEXION AT 20 DEGREES. COMPLICATIONS MENTIONED IN THE ARTICLE WERE: RE-RECONSTRUCTION WAS PERFORMED IN TWO CASES IN THE SINGLEBUNDLE RECONSTRUCTION GROUP AND ONE CASE IN THE DOUBLEBUNDLE RECONSTRUCTION GROUP. THERE WAS NO DIFFICULTY IN THE SURGICAL PROCEDURE DUE TO TUNNEL ENLARGEMENT. FROM THE REVIEW OF THIS ARTICLE IT IS CONCLUDED THAT MITEK DEVICES MENTIONED CANNOT BE DISASSOCIATED WITH COMPLICATION (RE-RECONSTRUCTION) NOTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626607 UNKNOWN BIO-INTRAFIX SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention