BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX

    MDR report key: 8748646 · Received July 1, 2019

    Report

    Report Number
    1221934-2019-57492
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    January 9, 2011
    Report Date
    June 14, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 RIGIDFIX CROSS PIN. 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. (B)(6). (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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: A.G. DUDHNIWALA ET AL. 2012, LATERAL MENISCAL TEAR RESULTING FROM THE FEMORAL CROSS-PIN USED FOR HAMSTRING GRAFT FIXATION IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, A.G. DUDHNIWALA ET AL. / THE KNEE 19 (2012) 951¿952, (UNITED KINGDOM). THE STUDY EMPHASIZES ON A CASE STUDY OF LATERAL MENISCAL TEAR RESULTING FROM THE FEMORAL CROSS-PIN USED FOR HAMSTRING GRAFT FIXATION IN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION. THE PATIENT WAS EVALUATED ON COURSE OF THIS STUDY: A (B)(6) MAN WAS PRESENTED WITH SYMPTOMS OF KNEE PAIN, CATCHING AND LOCKING, 13 MONTHS FOLLOWING AN ACL RECONSTRUCTION ALONG WITH PAST HISTORY OF INJURY TO HIS RIGHT KNEE WHILST PLAYING FOOTBALL RESULTING IN A COMPLETE ACL TEAR. ON CLINICAL EXAMINATION OF THE KNEE THERE WAS A MILD JOINT EFFUSION, TENDERNESS OVER THE LATERAL JOINT LINE AND A STABLE ACL ON PIVOT SHIFT AND LACHMAN TEST. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: DIGITAL ARTHROSCOPY WAS PERFORMED FOR ACL RECONSTRUCTION. NO UNTOWARD EVENTS WERE ENCOUNTERED DURING THE OPERATION AND SATISFACTORY GRAFT FIXATION AND KNEE STABILITY WERE ACHIEVED. TO INVESTIGATE THE CASE AFTER 13 MONTHS, MAGNETIC RESONANCE IMAGING (MRI) AND ARTHROSCOPY WERE PERFORMED WHICH CONFIRMED THE BROKEN FEMORAL CROSS-PIN ABUTTING THE LATERAL MENISCUS AND THE RESULTING MENISCAL TEAR ALONG WITH INFLAMMATION OF THE SURROUNDING SYNOVIUM. THE ACL GRAFT WAS INTACT AND FUNCTIONAL. THE BROKEN CROSS-PIN WAS REMOVED AND THE LATERAL MENISCUS WAS REPAIRED WITH MENISCAL SUTURES. THE DEVICES INVOLVED WERE 2 BIOABSORBABLE CROSS-PINS (RIGIDFIX.) ON FEMUR AND AN INTRAFIX SCREW ON THE TIBIA AND SHEATH WHILE ACL RECONSTRUCTION. COMPLICATIONS MENTIONED IN THE ARTICLE: LATERAL MENISCUS TEAR AND SYNOVIAL IRRITATION CAUSING KNEE PAIN, CATCHING AND LOCKING WERE REPORTED. FRACTURE OF THE DISTAL FEMORAL CROSS-PIN AT THE GRAFT-BONE JUNCTION AND ITS INTRA-ARTICULAR POSITION HAS BEEN POSTULATED AS THE CAUSE OF LATERAL MENISCUS TEAR AND SYNOVIAL IRRITATION. THIS ARTICLE ALREADY SHOWED THE POSSIBILITY OF FRACTURE OF THE CROSS-PINS THAT HAD BEEN REPORTED AS PRESENTING WITH LOOSE INTRA-ARTICULAR BODIES AND CAUSING CHONDRAL DAMAGE IN OTHER ARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541140 UNKNOWN BIO-INTRAFIX SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention