BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T4, SELF RETAINING,MINI AO

    MDR report key: 11475942 · Received March 12, 2021

    Report

    Report Number
    1220246-2021-02727
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 24, 2021
    Report Date
    June 2, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867313781
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-18700-09, BATCH 1391937 DRIVER SHAFT WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION THROUGH THE USE OF MICRO-VU ID: 654 IDENTIFIED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP WAS BOTH TWISTED AND BROKEN. MICRO-VU MEASUREMENTS REVEALED THAT APPROXIMATELY 0.12175" OF THE TIP REMAINED, WITH DESIGN TOLERANCES OUTLINING THE TIP LENGTH AS MEASURING BETWEEN 0.125"±.001". MATERIAL ANALYSIS TESTING IDENTIFIED THAT THE RETURNED AR-18700-09 DRIVER SHAFT MET COMPOSITION SPECIFICATIONS. BASED ON THE OBSERVED CONDITION OF THE DISTAL TIP AND ALL FINDINGS NOTED, THIS EVENT IS MOST LIKELY THE RESULT OF OVER-TORQUING THE DRIVER DURING USE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT DURING A PROXIMAL PHALANX FRACTURE OF THE 2ND FINGER REPAIR PROCEDURE, AS THE SURGEON WAS INSERTING THE SCREW WHEN THE TIP OF THE AR-18700-09, DRIVE SHAFT BROKE. THE BROKEN PIECE WAS REMOVED. THE SURGEON USED AN AR-18700-29, DRIVE SHAFT, FOR INSERTION OF THE LAST SCREW, THE SURGEON COULD FEEL THE TIP OF THE DRIVER WAS TWISTING AND BACKED OFF REMOVING THE AR-18700-29. THE CASE WAS COMPLETED LEAVING THE SCREW NOT FULLY SEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375190 DRIVER SHAFT, T4, SELF RETAINING,MINI AO ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T4, SELF RETAINING,MINI AO 00888867313781

    Patients

    Seq Age Sex Outcome Treatment
    1