BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK RIGIDFIX CROSS PIN

    MDR report key: 5027904 · Received August 25, 2015

    Report

    Report Number
    1221934-2015-00933
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    August 6, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    HTY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK MEDICAL AFFAIRS DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. IT CANNOT BE CONFIRMED THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED 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. 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

    THIS COMPLAINT WAS FORWARDED TO MITEK COMPLAINTS BY OUR MEDICAL AFFAIRS TEAM WHO REVIEWED A JOURNAL ARTICLE WHERE MITEK RIGIDFIX CROSS PINS WERE USED FOR AN ACL RECONSTRUCTION FOR A (B)(6) MALE. HE HAD RECONSTRUCTION SURGERY 9 YEARS AGO. REVISION SURGERY WAS PERFORMED 4 YEARS AGO FOR A RE-RUPTURED ACL. A THIRD RE-VISION SURGERY WAS DONE IN ANOTHER HOSPITAL. WITHIN (B)(6), THE PATIENT EXPERIENCED PAIN AND SWELLING AND WAS REFERRED TO A DIFFERENT HOSPITAL WHERE EMERGENCY SURGICAL EXPLORATION WAS PERFORMED. A GRETER SAPHENOUS VEIN AUTOGRAFT WAS HARVESTED FROM THE IPSILATERAL LIMB AND A REANASTOMOSIS PROCEDURE WAS PERFORMED. (B)(4) KNEE SURGERY & RELATED RESEARCH POPLITEAL ARTERY PSEUDOANEURYSM AFTER ANTERIOR CRUCIATE LIGAMENT RE-REVISION USING A RIGIDFIX CROSS PIN AUTHORS: GWANG CHUL LEE, MD DONG HWI KIM, MD SUNG-HAE PARK, MD

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562096 MITEK RIGIDFIX CROSS PIN ACL IMPLANTS HTY DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R