BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-PLATE, 1.6MM, 6 HOLE

    MDR report key: 11991255 · Received June 14, 2021

    Report

    Report Number
    1220246-2021-03275
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867313422
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE THE AR-18716P-10 PLATE WAS DAMAGED DURING THE ATTEMPTED CUT AND THE TIP OF THE AR-18700-09 DRIVER BROKE OFF INTO THE SCREW HEAD. ADDITIONAL INFORMATION PROVIDED 6/8/21: THE BROKEN TIP OF AR-18700-09 WAS UNABLE TO BE REMOVED FROM THE SCREW HEAD. THE DRIVER TIP BROKE COMPLETELY FLUSH WITHIN THE SCREW HEAD AND THE SURGEON WAS UNABLE TO REMOVE IT. THE CASE WAS COMPLETED BY REMOVING THE ENTIRE SCREW FROM THE PATIENT USING A NEEDLE NOSE PLIERS, AND USING A LESS OPTIMAL PLATE BECAUSE THE MOST OPTIMAL PLATE WE NEEDED WAS BENT DURING AN ATTEMPTED CUT. BOTH DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893151 Y-PLATE, 1.6MM, 6 HOLE PLATE, FIXATION, BONE HRS ARTHREX, INC. Y-PLATE, 1.6MM, 6 HOLE UNK 00888867313422

    Patients

    Seq Age Sex Outcome Treatment
    1