BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX

    MDR report key: 8836509 · Received July 29, 2019

    Report

    Report Number
    1221934-2019-57834
    Event Type
    Injury
    Date Received
    July 29, 2019
    Report Date
    July 9, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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: UNK - GUIDES/SLEEVES - RIGIDFIX, 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: PIOTR WÓJCICKI ET AL ,2005, "ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH ST GRAFTS AND RIGIDFIX AND INTRAFIX FIXATION DEVICES" POLISH ORTHOPEDICS AND TRAUMATOLOGY, 70 (1), PAGE NO:9-12, POLAND. THE STUDY EMPHASIZES ON THE CLINICAL OUTCOMES OF ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WHEN PERFORMED WITH ST GRAFTS AND RIGIDFIX AND INTRAFIX FIXATION DEVICES. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: BETWEEN JANUARY 2000 AND DECEMBER 2001, 563 PATIENTS(18-55 YEARS ) (MEAN AGE-30 YEARS OLD) WITH TRAUMA INDUCED KNEE DYSFUNCTION WERE TREATED AT LORO. AMONGST THIS GROUP 79 PATIENT WERE DIAGNOSED WITH PARTIAL AND 43 WITH TOTAL ANTERIOR CRUCIATE LIGAMENT INJURY. 17 ACL RECONSTRUCTIONS WERE PERFORMED, UTILIZING SEMITENDINOSUS MUSCLE TENDONS AND GRACILIS MUSCLE TENDONS. THE INCLUSION CRITERIA WERE: OCCURENCE OF TRAUMA DUE TO PARTICIPATION IN RECREATIONAL SPORTS , ACCIDENTS AT WORK,5 PATIENTS WHO UNDERWENT PARTIAL MENISCECTOMY, THREE PATIENTS WITH CARTILAGE REPAIR. THE EXCLUSION CRITERIA WERE: SECONDARY DEGENERATIVE IRREGULARITIES, EXTREMELY LIMITED MOBILITY, EXTENSION DEFICITS, LACK OF PHYSICAL FITNESS ASSOCIATED WITH AGE. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WAS PERFORMED BY HARVESTING FLEXOR TENDONS: SEMITENDINOSUS AND GRACILIS MUSCLE. ALL THE 17 PATIENTS UNDERWENT A FOLLOW UP ON AVERAGE 10 MONTHS AFTER SURGERY. THE DEVICES INVOLVED WERE: A TIBIAL GUIDE DEVICE WAS UTILIZED TO INTRODUCE A K-WIRE, IN ARTHROSCOPIC PREPARATION OF THE JOINT. ABSORBABLE CROSS PINS WERE INTRODUCED VIA CANNULAS INSERTED INTO THE TUNNELS WHILST KEEPING THE GRAFT UNDER TENSION. IN ORDER TO FINALIZE THE SURGICAL PROCEDURE AN INTRAFIX SHEATH AND SCREW ARE USED FOR TIBIAL FIXATION. COMPLICATIONS MENTIONED IN THE ARTICLE WERE: CONTINUED DISCHARGE FROM THE WOUND AND LIMITED KNEE FLEXION WAS OBSERVED IN 3 CASES POSTOPERATIVELY. FROM THE REVIEW OF THIS ARTICLE IT IS CONCLUDED THAT MITEK DEVICES MENTIONED CANNOT BE DISASSOCIATED WITH ANY COMPLICATION NOTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629983 UNKNOWN BIO-INTRAFIX SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention