BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T8, SELF RETAINING, AO

    MDR report key: 19890883 · Received August 2, 2024

    Report

    Report Number
    1220246-2024-06998
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 10, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    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 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 16 JULY 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT BOTH AN AR-8916-14 DRILL BIT, 1.7MM AND AN AR-18700-54 DRIVER SHAFT, T8, SELF RETAINING, AO, BROKE DURING USE. THIS OCCURRED ON 10 JULY 2024 IN FLINDERS MEDICAL CENTRE DURING A NAVICULAR ORIF. USING ARTHREX EQUIPMENT FOR OPEN REDUCTION INTERNAL FIXATION 1.7MM DRILL BIT (REF: AR-8916-14) SNAPPED AT DRILL TIP. 2.4MM T8 SCREWDRIVER (REF: AR-18700-54) SNAPPED WHILE SCREWING LOCKING SCREW INTO LOCKING PLATE. AR-18724P-54 PLATE REMOVED FROM PATIENT AS SCREW THREAD SECURED INTO PLATE AND UNABLE TO BE REMOVED. ALL ARTHREX STOCK REMOVED AND DISCARDED. THE CASE WAS COMPLETED SUCCESSFULLY USING A SYNTHES VA FOOT SET. THERE WAS CASE INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885426 DRIVER SHAFT, T8, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T8, SELF RETAINING, AO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown