BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCHCUT REAMER KIT 4.5MM 9.0MM

    MDR report key: 10777404 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-02920
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    April 6, 2020
    Report Date
    April 6, 2020
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    01081019001388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING INVESTIGATION AFTER INSPECTION OF THE RETURNED DEVICE - SHARED PIN DAMAGE MARKS ON THE REAMER SIDES CAME TO ROOT CAUSE OF THIS FAILURE IS MISUSE AND NOT FOLLOWING THE IFU INSTRUCTIONS.

    Description of Event or Problem · 1

    DR (B)(6) WAS PERFORMING A REVISION ACL USING THE SWITCHCUT SYSTEM. WHEN HE WENT TO DRILL THE 4.5X9.5 SWITCHCUT REAMER THROUGH THE FEMUR, AND BEFORE HE REVERSE REAMED HIS FEMORAL TUNNEL TO A 9.5, HE NOTICED THAT THE DRILL PIECE WAS MISSING. THE SMALL FLAP PIECE THAT OPENS WHEN THE DRILL IS PUT IN REVERSE WAS NO LONGER ATTACHED TO THE DRILL. WE THEN BROUGHT IN X RAY AND WE LOCATED THE DRILL PIECE IN THE TIBIAL TUNNEL AND IT WAS RECOVERED. BOTH THE DRILL AND THE BROKEN PIECE WILL BE SENT BACK. A SECOND 9.5 SWITCHCUT REAMER WAS OPENED AND USED TO DRILL THE FEMORAL TUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241061 SWITCHCUT REAMER KIT 4.5MM 9.0MM SWITCHCUT REAMER KIT 4.5MM 9.0MM MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD 110027681 17C08 01081019001388

    Patients

    Seq Age Sex Outcome Treatment
    1