BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 20108859 · Received August 30, 2024

    Report

    Report Number
    1220246-2024-07326
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 9, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-8750-03 DRIVER SHAFT BATCH NUMBER: 1392204 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT A PIECE OF THE HEX DRIVE GEOMETRY AT THE DISTAL TIP OF THE RETURNED AR-8750-03 DRIVER SHAFT HAD BROKEN OFF. NO PIECES WERE RETURNED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE BROKEN DISTAL TIP OF THE DEVICE. IT WAS NOT INDICATED IF A TORQUE-INDICATING ADAPTER HAD BEEN USED WITH THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8750-03 DRIVER SHAFTS BROKE. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

    Description of Event or Problem · 0

    ON 08/15/2024 ADDITIONAL INFORMATION WAS PROVIDED BY A SALES REPRESENTATIVE VIA EMAIL WHO STATED THAT THE EVENT DATE WAS 08/08/2024. THE PROCEDURE PERFORMED WAS A HARDWARE REMOVAL. THE CANNULATED HEAD BROKE OFF FOR BOTH DRIVERS. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. A SOLID DRIVER WAS USED TO FINISH THE PROCEDURE WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910820 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. 031833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown