BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM FLEXIBLE REAMER

    MDR report key: 10777410 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-03020
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    April 21, 2020
    Report Date
    April 21, 2020
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    10810190016067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    YES DEVICE BROKEN AT THE JOINT BETWEEN THE SHAFT AND THE FLEXIBLE PART. OUR ENGINEERING INVESTIGATION DETERMINES THAT AS TO THE PICTURES PROVIDED THE BREAKAGE HAPPENED BETWEEN THE FLEXIBLE AND THE STIFF PART OF THE DEVICE EXPLAINING THAT EXCESSIVE FORCE WAS APPLIED CAUSING THE BREAK

    Description of Event or Problem · 1

    DURING THE ACL REPAIR SURGICAL PROCEDURE, DR (B)(6), HAVING PERFORMED THE FEMORAL TUNNEL TO PASS THE PROCINCH BUTTON, THE VERSITOMIC BIT (4.5MM) BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241068 4.5MM FLEXIBLE REAMER 4.5MM FLEXIBLE REAMER MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD 234-108-045 19B01 10810190016067

    Patients

    Seq Age Sex Outcome Treatment
    1