BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAX 5.5 CT SPINAL SYSTEM

    MDR report key: 11735786 · Received April 27, 2021

    Report

    Report Number
    9617297-2021-00007
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 28, 2021
    Manufacturer
    U&I CORPORATION
    Product Code
    HXX
    UDI-DI
    08800015999854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 12TH OF 2021, DURING THE SPINAL FUSION SURGERY, THE THREAD OF THE CT DRIVER'S DISTAL TIP WHERE A SCREW IS CONJUNCT WITH ITS HEAD BROKE OFF WHILE INSERTING THE SCREW INTO THE PATIENT. BASED ON THE DESIGN INTENTION, A USER SHOULD CONDUCT THREADING AFTER MAKING SURE THE HEX PART FULLY CONNECTS TO THE SCREW. HOWEVER, IF THE USER DOESN'T MAKE THE HEX PART OF THE DRIVER'S DISTAL TIP NOT FULLY PROJECTED ENOUGH TO BE CONNECTED TO THE SCREW, THE THREAD PART COULD BE BROKEN DURING INSERTING THE SCREW AS THE STRESS CONCENTRATES ON ONLY THE THREAD PART. SO THE THREAD PART OF THE DRIVER MAY BE BROKEN. CONCERNING IT, WE GAVE THE USER THE PRECAUTIONS FOR ASSEMBLING THE INSTRUMENT COMPONENTS. ALTHOUGH THIS PROBLEM OCCURRED FOR THE FIRST TIME RESULTING FROM THE USER ERROR, WE DETERMINED TO CHANGE THE DESIGN OF THE DRIVER TO COMPLEMENT VOLUNTARILY EVEN TO THAT EXTENT. SO WE DON'T NEED THE RECALL PROCESS. BESIDES, THE THICKNESS OF THE SAME LOT(19I09040)'S THREAD PART IN THE DISTAL TIP WAS MEASURED TO SEE THE POSSIBILITY OF NONCONFORMITY IN THE MANUFACTURING PROCESS AND WE CONFIRMED THE CONFORMITY.

    Description of Event or Problem · 1

    INSERTED THREADS BROKE OFF INTO THE INSERTER, IT IS NOT ABLE TO ADVANCE THE SCREW IN ANYMORE OR REMOVE CAUSE THE THREADS BROKE IN THE SCREW. THE THREADS SEARED OFF INSIDE OF THE SCREW, THE SCREW WAS FINE THE SURGEON JUST WAS NOT ABLE TO ADVANCE THE SCREW ANYMORE NOR WAS HE ABLE TO TAKE IT OUT BECAUSE THE THREADS WERE STILL SCREWED INSIDE THE SCREW HEAD. HE NEEDED TO SCREW A COUPLE MORE TURNS BUT IT WAS OK AND DOWN ENOUGH HE COULD WORK WITH IT. THE BROKEN THREAD LEFT INSIDE OF THE SCREW HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632037 ANAX 5.5 CT SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXX U&I CORPORATION CT0010 19I09040 08800015999854

    Patients

    Seq Age Sex Outcome Treatment
    1