BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRV SFT,T8 HEXALOBE CANN,STR

    MDR report key: 17112386 · Received June 12, 2023

    Report

    Report Number
    1220246-2023-06907
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 19, 2023
    Report Date
    February 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867046207
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    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 USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION AND/OR USER-APPLIED MECHANICAL FORCES DURING INSERTION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-16 AND AN AR-8737-25 , 2.4 AND 3.0 CANNULATED DRIVERS BROKE DURING A CASE DUE TO WEAR AND TEAR. PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509502 DRV SFT,T8 HEXALOBE CANN,STR MANUAL INSTR, GENERAL SURGICAL LXH ARTHREX, INC. DRV SFT,T8 HEXALOBE CANN,STR 1392009 00888867046207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown