BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T10 HEXALOBE, CANNULATED

    MDR report key: 11627302 · Received April 7, 2021

    Report

    Report Number
    1220246-2021-02840
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 17, 2021
    Report Date
    June 8, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867046115
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE AR-8737-16 RETURNED HAS A TWISTED AND BROKEN DRIVE FEATURE. THE DEVICE IS MISSING APPROXIMATELY .05 IN. RELEVANT FEATURES COULD NOT BE MEASURED BECAUSE OF THE DAMAGE AND DEFORMATION, HOWEVER REVIEW OF THE CERTIFICATE OF CONFORMANCE REVEALS THE DEVICE MEETS MATERIAL SPECIFICATIONS. THE CAUSE OF THE EVENT IS UNDETERMINED. LIKELY CAUSES INCLUDED OVERTORQUING THE DEVICE; PRYING/LEVERAGING DURING USE; SHALLOW DRIVER ENGAGEMENT DEPTH.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE AR-8737-16 RETURNED HAS A TWISTED AND BROKEN DRIVE FEATURE. THE DEVICE IS MISSING APPROXIMATELY .05 IN. RELEVANT FEATURES COULD NOT BE MEASURED BECAUSE OF THE DAMAGE AND DEFORMATION, HOWEVER REVIEW OF THE CERTIFICATE OF CONFORMANCE REVEALS THE DEVICE MEETS MATERIAL SPECIFICATIONS. THE CAUSE OF THE EVENT IS UNDETERMINED. LIKELY CAUSES INCLUDED OVERTORQUING THE DEVICE; PRYING/LEVERAGING DURING USE; SHALLOW DRIVER ENGAGEMENT DEPTH.

    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 THE TIP OF THE AR-8737-16 BROKE OFF DURING INSERTION. THE SALES REP REPORTED ALL BROKEN FRAGMENTS WERE FULLY RETRIEVED. THERE WAS NO NEGATIVE OUTCOME, AND THE CASE WAS COMPLETED BY USING ANOTHER DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529197 DRIVER SHAFT, T10 HEXALOBE, CANNULATED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T10 HEXALOBE, CANNULATED 1391820 00888867046115

    Patients

    Seq Age Sex Outcome Treatment
    1