BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 12770502 · Received November 8, 2021

    Report

    Report Number
    1220246-2021-03893
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. TWO UNPACKAGED AR-8737-38, BATCH 1392008 DRIVERS WERE RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT BOTH RETURNED DRIVERS HAD BROKEN AT THE DISTAL TIP, WITH NO FRAGMENTS RETURNED FOR ANALYSIS. ADDITIONALLY, IT WAS OBSERVED THAT THE DRIVE GEOMETRIES OF BOTH AR-8737-38 DEVICES WERE TWISTED, INDICATING THAT THE DEVICES HAD BROKEN UNDER TORSION. THE CAUSE REMAINS UNDETERMINED, ALTHOUGH A PROBABLE CAUSE CAN BE ATTRIBUTED TO OVER-TORQUING/OVER-ENGAGING THE DRIVERS DURING USE.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    MULTIPLE SCREW DRIVERS BROKE DURING AN IMPLANT REMOVAL SURGERY. FIRST AR-8737-38: 1.1MM GUIDEWIRE WAS INSERTED INSIDE THE 4MM COMP FT SCREW TO GUIDE THE SCREW DRIVER UNDER X-RAY, SCREW DRIVER INSERTED THEN FOLLOWED BY TWO MORE X-RAY(AP&LATERAL) TO CONFIRM THE ALIGNMENT, FIRST SCREW DRIVER(AR-8737-38) BROKE AFTER 2-3 TURNS, HAVE TO EXTEND THE INCISION TO REMOVE 2 SMALL BROKEN PIECES BEFORE THE 2ND TRY. SECOND AR-8737-38: ANOTHER NEW 1.1MM GUIDEWIRE WAS INSERTED FOR GUIDING THE SCREW DRIVER WITH X-RAY CONFIRMATION SAME AS THE PREVIOUS ONE. SCREW DRIVER TIP WAS TWISTED WHILE TURNING. ABLE TO REMOVE THE SCREW WITH THE TWISTED SCREW DRIVER. 3RD SCREW DRIVER(AR-8737-37): 0.86MM GUIDEWIRE WAS INSERTED INSIDE THE 2.5MM COMP FT SCREW TO GUIDE THE SCREW DRIVER UNDER X-RAY, SCREW DRIVER INSERTED THEN FOLLOWED BY TWO MORE X-RAY(AP&LATERAL) TO CONFIRM THE ALIGNMENT, SCREW DRIVER TIP BROKE INSIDE SCREW AFTER 2-3 TURNS, BROKEN PIECE COULD NOT BE REMOVED. CAN SEE ENHANCED SHADOW ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663002 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T10 HEXALOBE, CMP FT UNK 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown