BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK RIGIDFIX

    MDR report key: 3583815 · Received January 21, 2014

    Report

    Report Number
    1221934-2014-00027
    Event Type
    Injury
    Date Received
    January 21, 2014
    Report Date
    January 7, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR PATIENT SAFETY DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. WE CANNOT CONFIRM THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO WE ARE FILING AN ADVERSE EVENT REPORT TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE FOLLOWING ISSUE WAS DISCOVERED VIA A PUBLISHED INDIVIDUAL CASE REPORT BY THE MITEK SAFETY OFFICER: INDIVIDUAL CASE REPORTS (COMPLICATIONS). AUTHOR: HAN ET AL (2005) SOUTH KOREA REFERENCE: HAN I, KIM YH, YOO JH, SEONG SC, KIM TK. BROKEN BIOABSORBABLE FEMORAL CROSS-PIN AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT: A CASE REPORT. AM J SPORTS MED. 2005 NOV;33(11):1742-5. ADDRESS: TAE KYUN KIM, MD, PHD, JOINT RECONSTRUCTION CENTER, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL, 300 GUMI-DONG, BUNDANG-GU, SEONGNAM-SI, GYEONGGI-DO (463-707), KOREA E-MAIL: [email protected] PATIENT CHARACTERISTICS: AGE: (B)(6), GENDER: MALE. TYPE OF LESION: ACL TEAR, MENISCUS TEAR (X2). PERIOPERATIVE COMPLICATIONS: JOINT: KNEE. ANCHOR (# PER LESION): RIGIDFIX CROSS PINS SUTURE: - OTHER DEVICES: INTRAFIX (TIBIA), STAPLE. TECHNIQUE: ACL RECONSTRUCTION (TT, 4 STRAND HAMSTRING ALLOGRAFT), REPAIR/RESECTION OF MENISCUS SURGICAL COMPLICATIONS: - ANESTHESIA COMPLICATIONS: - DEVICE COMPLICATIONS: ¿FEMORAL TUNNEL WAS NOT MADE PROPERLY AND BLOWOUT OF THE POSTERIOR WALL OCCURRED.¿ OTHER COMPLICATIONS: - TIME COMPLICATION: 14 MO. F/U TIME: 6 MO. LOOSE DEVICE: BROKEN RIGIDFIX PIN IN POPLITEAL HIATUS, SUDDEN, PAINFUL, CATCHING SENSATION WHILE TRYING TO EXTEND THE KNEE, LOCATION OF THE PAIN MIGRATED, MILD EFFUSION, LACHMAN AND ANTERIOR DRAWER TESTS MILDLY POSITIVE, PIVOT-SHIFT TEST SHOWED SUBTLE GLIDING, MCMURRAY TEST NEGATIVE, PALPATION REVEALED NO TENDERNESS. BROKEN SUTURE: - TISSUE DAMAGE: NEW MENISCUS TEAR, ACL GRAFT INTACT (INTACT GRAFT, POSSIBLE MENISCAL TEAR), IMAGING STUDIES: MRI: X-RAY: TIBIAL TUNNEL MORE VERTICAL THAN RECOMMENDED. REOPERATION (RELATED/UNRELATED): RELATED: SURGERY (AUTHORS CLAIMED TOW TECHNICAL MISTAKES), INDICATED FOR MENISCUS TEAR, BROKEN RIGIDFIX PIN FOUND, OUTCOMES: OBJECTIVE OUTCOMES: LACHMAN AND ANTERIOR DRAWER TESTS MILDLY POSITIVE, KT-1000. ARTHROMETER (MAXIMUM DIFFERENCE OF ANTERIOR TIBIAL TRANSLATION): 1.5 MM. FUNCTIONAL OUTCOMES: RETURNED TO FULL ACTIVITY WITHOUT ANY COMPLICATIONS. SUBJECTIVE OUTCOMES: SUDDEN PAINFUL, CATCHING SENSATION WHILE TRYING TO EXTEND THE OPERATED KNEE. PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47237 MITEK RIGIDFIX SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention