BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 15698325 · Received October 31, 2022

    Report

    Report Number
    1220246-2022-05677
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 11, 2022
    Report Date
    January 4, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. UPON VISUAL INSPECTION IT WAS NOTED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP OF THE RETURNED AR-8737-38 HAD BROKEN OFF. NO FRAGMENTS WERE RETURNED FOR INSPECTION. A PROBABLE CAUSE IS ATTRIBUTED TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD. THE CAUSE REMAINS UNDETERMINED.

    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

    ON 10/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-38 DRIVER SHAFT, T10 HEX, CANNULATED HAD AN ISSUE, THE TIP BROKE OFF, STAR T DRIVER SHATTERED AT THE TIP. DISCOVERED DURING CASE, REP WILL FOLLOW UP WITH X-RAY, FRAGMENTS WERE RETRIEVED AND WERE NOT LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2022 WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/20/2022, THE SALES REPRESENTATIVE WHO ATTENDED THE CASE, PROVIDED THE FOLLOWING INFORMATION VIA MAIL: THIS EVENT OCCURRED DURING AN ORIF METACARPAL PROCEDURE. SHE ARRIVED LATE IN THE CASE THAT DAY AND WAS NOT ABLE TO CONFIRM IF X-RAYS WERE TAKEN TO VERIFY IF ANY FRAGMENTS WERE LEFT INSIDE THE PATIENT. NO DRILL GUIDE WAS USED AND THE INSTRUMENT WAS NOT USED WITH POWER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2950646 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1392107 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown