BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 19434299 · Received May 31, 2024

    Report

    Report Number
    1220246-2024-04504
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    May 2, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-8737-38 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, IT WAS NOTED THAT THE CANNULATED DRIVER TIP WAS BROKEN OFF. THE OVERALL LENGTH MEASURE FROM THE PROXIMAL END OF THE SHAFT TO THE LOWER BROKEN PART OF THE TIP GIVES A RESULT OF 3.11 IN, INDICATING THE DEVICE IS SHORTER DUE TO THE FRACTURED PART OF THE TIP. DRAWING USED FOR OVERALL LENGTH SPECIFICATIONS C4943 AT REVISION 12. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE DRIVER WHILE ENGAGED WITH THE SCREW.

    Description of Event or Problem · 0

    ON 05/02/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-38 DRIVER SHAFT TIP BROKE OFF. THIS OCCURRED DURING AN ORIF OF THE METACARPAL ON (B)(6) 2024 WHILE INSERTING A 3.5 COMP FT SCREW INTO THE THIRD METACARPAL. AS THE SCREW REACHED THE FRACTURE LINE, THE TIP OF THE SCREWDRIVER BROKE OFF THE TOP OF THE DRIVER INTO THE SCREW. THE DRIVER WAS TAKEN OFF THE FIELD AND THE FRAGMENTS OF THE DRIVER WERE REMOVED BY THE SURGEON WITH FORCEPS. X-RAY WAS TAKEN TO ENSURE NO PIECES WERE LEFT IN THE PATIENT. THE SURGERY CONTINUED AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330180 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1391536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown