BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP INSTR. KIT FOR TENO SCRW

    MDR report key: 18104095 · Received November 9, 2023

    Report

    Report Number
    1220246-2023-08653
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    October 20, 2023
    Report Date
    January 17, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    UDI-DI
    00888867020801
    PMA / PMN Number
    K041553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED BASED ON THE CUSTOMER¿S ATTACHED X-RAY (CASE (B)(4) CUSTOMER X-RAY.JPG), WHICH DISPLAYS A PIECE OF AN ALLEGED AR-1676DS BROKEN. 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 CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED AND OBSERVED FAILURE IS USER ERROR. SPECIFICALLY, THE ERROR INVOLVED IMPROPER BONE PREPARATION, MISALIGNED INSERTION, OR PRYING/LEVERAGING THE DEVICE DURING INSERTION. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE AND THE BONE QUALITY ENCOUNTERED WERE NOT PROVIDED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1676DS BIO-TENODESIS¿ DISPOSABLE KITS DRIVER TIP BROKE OFF INSIDE THE PATIENT. THIS OCCURRED DURING A FHL TENDON TRANSFER ON (B)(6) 2023, ONCE THE SURGEON HAD DRILLED THROUGH THE BONE THE DEVICE DID NOT LOOK RIGHT. THE END LOOKED SMALLER THAN NORMAL. AN X-RAY WAS TAKEN AND IT APPEARED AS IF THE EYELET WAS CUT OUT INTO THE TIP OF THE DRILL BIT THAT BROKE IN THE BONE. THE FRAGMENT REMAINS IN THE PATIENT. CASE WAS COMPLETED USING ANOTHER AR-1676DS BIO-TENODESIS¿ DISPOSABLE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102532 DISP INSTR. KIT FOR TENO SCRW POLYETHYLENE SYNTHETIC SUTURE GAT ARTHREX, INC. DISP INSTR. KIT FOR TENO SCRW 15087622 00888867020801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown