BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK RIGIDFIX

    MDR report key: 3584020 · Received January 21, 2014

    Report

    Report Number
    1221934-2014-00029
    Event Type
    Injury
    Date Received
    January 21, 2014
    Report Date
    January 16, 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: LIM ET AL (2010) SOUTH KOREA REFERENCE: LIM HC, BAE JH, WANG JH, SEOK CW, KIM MK. FRACTURE OF THE TIBIAL BONE BLOCK AFTER POSTERIOR CRUCIATE LIGAMENT ALLOGRAFT RECONSTRUCTION USING DOUBLE CROSS PINS. ARCH ORTHOP TRAUMA SURG. 2009 NOV 17. ADDRESS: H. C. LIM ¿ J. H. BAE (&) ¿ C. W. SEOK ¿ M. K. KIM DEPARTMENT OF ORTHOPAEDIC SURGERY, KOREA UNIVERSITY COLLEGE OF MEDICINE, GURO HOSPITAL, 80 GURO-DONG, GURO-GU, SEOUL 152-703, REPUBLIC OF KOREA E-MAIL: [email protected] PATIENT CHARACTERISTICS AGE: (B)(6). GENDER: MALE. TYPE OF LESION: PCL TEAR, MENISCUS TEAR. PERIOPERATIVE COMPLICATIONS JOINT: KNEE. ANCHOR (# PER LESION): RIGIDFIX BIOABSORBABLE PINS FOR TIBIA. SUTURE: - OTHER DEVICES: INTERFERENCE SCREW (LINVATEC) FOR TIBIA, INTERFERENCE SCREWS FOR FEMUR. TECHNIQUE: PCL RECONSTRUCTION (ACHILLES TENDON-BONE ALLOGRAFT, 2 BUNDLES, AL, PM PORTALS FOR FEMORAL TUNNELS), PARTIAL MENISECTOMY. SURGICAL COMPLICATIONS: - ANESTHESIA COMPLICATIONS: - DEVICE COMPLICATIONS: - OTHER COMPLICATIONS: - TIME COMPLICATION: 3 MO. F/U TIME: 8 MO. LOOSE DEVICE: NO BROKEN PINS. BROKEN SUTURE: TISSUE DAMAGE: SUDDEN SWOLLEN AND PAINFUL SENSATION WHILE TRYING TO FLEX THE KNEE IMAGING STUDIES: MRI FRACTURE OF THE GRAFT¿S BONE BLOCK AT THE LEVEL OF PROXIMAL CROSS PIN, INCONTINUITY OF TIBIAL ATTACHMENT OF PCL GRAFT, MILD JOINT EFFUSION. REOPERATION (RELATED/UNRELATED): POSSIBLY RELATED (FRACTURE AT THE LEVEL OF THE CROSS PIN), REVISION SURGERY USING MODIFIED OPEN INLAY TECHNIQUE, FIXATION OF BONE PLUG IN CORTICAL WINDOW WITH CANCELLOUS SCREW AND SPIKED WASHER. OUTCOMES OBJECTIVE OUTCOMES: POSTERIOR DRAWER TEST WAS NEARLY NORMAL. FUNCTIONAL OUTCOMES: IKDC GRADE B. SUBJECTIVE OUTCOMES: - PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47631 MITEK RIGIDFIX SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention