BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER 8.5MM

    MDR report key: 6968142 · Received October 23, 2017

    Report

    Report Number
    8043971-2017-00004
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    June 8, 2017
    Report Date
    August 27, 2017
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING AN ACL RECONSTRUCTION PROCEDURE THAT THE SURGEON WAS REAMING INTO THE FEMUR. THE SURGEON WAS AT THE DEPTH OF 30M AND UPON GETTING TO 28MM THE REAMER BROKE FROM THE FLEXIBLE PORTION TO THE RIGID. THE ENTIRE FLEXIBLE PORTION WAS STUCK IN THE KNEE. ONCE THE GUIDE PIN WAS PULLED, SURGEON WAS ABLE TO USE A HEMOSTAT THRU THE MEDICAL PORTAL TO WORK THE BROKEN SECTION OF THE FLEXIBLE REAMER FROM THE FEMUR DOWN THE TIBIA TUNNEL. EVERYTHING WAS REMOVED FROM THE PATIENT. THERE WAS A TEN MINUTE DELAY IN THE CASE. THE SURGEON WAS COMFORTABLE WITH THE 28MM DEPTH AND COMPLETED THE ACL PROCEDURE SUCCESSFULLY. DID NOT OPEN AND ADDITIONAL ACL DEVICES. REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747482 REAMER 8.5MM REAMER 8.5MM HTO T.A.G. MEDICAL PRODUCTS CORPORATION LTD AR-1400-85 17C20

    Patients

    Seq Age Sex Outcome Treatment
    1