BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK RIGIDFIX

    MDR report key: 3583753 · Received January 21, 2014

    Report

    Report Number
    1221934-2014-00024
    Event Type
    Injury
    Date Received
    January 21, 2014
    Report Date
    January 13, 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: CHEN ET AL (2007) US REFERENCE: CHEN N.C. BOYKIN R.E. MILLETT P.J. BROKEN FEMORAL CROSS PIN AFTER HAMSTRING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: CASE REPORT. THE JOURNAL OF KNEE SURGERY. 20 (3) (PP 245-248), 2007. ADDRESS: N.C. CHEN, MASSACHUSETTS GENERAL HOSPITAL HAND AND UPPER EXTREMITY FELLOWSHIP, BOSTON, MASS 02114, USA. UNITED STATES. PATIENT CHARACTERISTICS: AGE: (B)(6). GENDER: FEMALE. TYPE OF LESION: ACL TEAR. - - - - PERIOPERATIVE COMPLICATIONS JOINT: KNEE ANCHOR (# PER LESION): RIGIDFIX BIOABSORBABLE PINS (2). SUTURE: - OTHER DEVICES: - TECHNIQUE: ACL RECONSTRUCTION (4 STRAND HAMSTRING). SURGICAL COMPLICATIONS: - ANESTHESIA COMPLICATIONS: - DEVICE COMPLICATIONS: - OTHER COMPLICATIONS: - TIME COMPLICATION: 2 YRS. F/U TIME: - LOOSE DEVICE: BROKEN PIN. BROKEN SUTURE: TISSUE DAMAGE: DIAGNOSTIC ARTHROSCOPY: LOOSE PIN IN THE ANTERIOR COMPARTMENT OF THE KNEE, GRAFT INTACT AND WELL FIXED, IMAGING STUDIES: MRI: PIN MAY HAVE VIOLATED NOTCH. REOPERATION (RELATED/UNRELATED): RELATED: ARTHROSCOPY - OBJECTIVE OUTCOMES: - FUNCTIONAL OUTCOMES: - SUBJECTIVE OUTCOMES: KNEE CATCHING, LOCKING, AND STIFFNESS, RETURNED TO FULL ACTIVITIES POSTOPERATIVELY PATIENT SATISFACTION: -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50270 MITEK RIGIDFIX SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention