BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 17644658 · Received August 29, 2023

    Report

    Report Number
    1220246-2023-07660
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    July 11, 2023
    Report Date
    December 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263765
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO MISUSE DUE TO USE ERROR OF OVER-TORQUING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 07/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-8750-03 DRIVER SHAFTS, AND (2) AR-8750-06 DRIVER SHAFTS FAILED TO REMOVE SCREWS. THIS OCCURRED DURING A CASE ON (B)(6) 2023, THE PROPER TECHNIQUE WAS USED HOWEVER THE SURGEON WAS UNABLE TO SUCCESSFULLY REMOVE THE SCREWS WITH THE PROPER EQUIPMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 08/01/2023, IT WAS REPORTED THAT THE DRIVERS ARE TWISTED ON MOST AND THE TIP BROKE OFF OF ONE COMPLETELY, THE REPRESENTATIVE WAS UNSURE OF WHICH DEVICE BROKE. ADDITIONAL INFORMATION WAS PROVIDED ON 08/16/2023, THE DRIVERS FROM THE SET WERE USED IN AN ATTEMPT TO REMOVE THE SCREWS, BUT THEY WERE UNSUCCESSFUL. THEY HAD TO USE A SYNTHES SCREW REMOVAL SET WITH SEVERAL OTHER DRIVERS AND LARGER, DEEPER, TREPHINES TO GET THE SCREWS OUT. ONE OF THE 2 SCREWS BROKE AND ONLY A PORTION OF THE SCREW WAS RETRIEVED. THEY BELIEVE THE SCREW WAS 40MM LONG AND THEY REMOVED ABOUT 15-20MM OF THE BROKEN SCREW. THEY LEFT THE REST IN AS THEY DIDN¿T FEEL IT WAS SAFE OR RESPONSIBLE TO TRY TO GET THE REST OF IT OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058506 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. 011923 00888867263765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown