BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4 X 18MM VAL SCREW, TI

    MDR report key: 10460714 · Received August 27, 2020

    Report

    Report Number
    1220246-2020-02103
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    May 1, 2020
    Report Date
    August 27, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867045613
    PMA / PMN Number
    K131474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A PROCEDURE (B)(6) 2020. THE FIRST WEEK OF (B)(6) 2020 THE PATIENT HAD A FOLLOW UP VISIT AT THE SURGEON'S OFFICE AND X-RAYS TAKEN DURING THE FOLLOW UP SHOWED A FOREIGN BODY IS PRESENT. THE ITEM HAD NOT BEEN SEEN ON THE INTRAOPERATIVE X-RAYS TAKEN AT THE TIME OF PROCEDURE. IT WAS ALSO REPORTED THAT THE FOREIGN BODY IS NOT CAUSING ANY PAIN OR DISCOMFORT TO THE PATIENT. SURGEON BELIEVES THAT THE FOREIGN BODY MAY BE A THIN SHAVING FROM THE NARROW ULNAR PLATE/PLATE SCREWS THAT HAD BEEN IMPLANTED. SURGEON ALSO INDICATED THAT HE HAS SEEN THIS OCCUR PREVIOUSLY WITH THE ARTHREX SYSTEM THAT WAS USED. (INFORMATION HAS BEEN REQUESTED REGARDING THESE INSTANCES.) THE SHAVING WAS NOT NOTICED AT THE TIME OF OCCURRENCE TO DETERMINE THE SPECIFIC PRODUCT THE SHAVING MAY HAVE COME FROM. AT THIS TIME THE SURGEON DOES NOT HAVE PLANS TO REMOVE THE HARDWARE OR FOREIGN BODY BUT THE SALES REPRESENTATIVE HAS REQUESTED THAT THE SURGEON NOTIFY HIM IF A SECOND SURGERY IS SCHEDULED. THE FOLLOWING ARE THE PLATE AND SCREWS THAT WERE USED DURING THE (B)(6) 2020 PROCEDURE: AR-8916VNL-03, VOLAR DISTAL RADIUS PLATE, LOT 10440051. AR-8724-18, LOW PROFILE SCREW, LOT W652321. AR-8724V-16, VAL SCREW, LOT W689081. AR-8724V-18, VAL SCREW, LOT 1204022. AR-8724V-18, VAL SCREW, LOT W698661 AR-8735-10, LOW PROFILE SCREW CORTICAL, LOT 2698961. AR-8735-11, LOW PROFILE SCREW CORTICAL, LOT 2689741. AR-8735-13, LOW PROFILE SCREW CORTICAL, LOT 2689771. AR-8735-14, LOW PROFILE SCREW CORTICAL, LOT 2716281. AR-8735L-12, LOW PROFILE LOCKING SCREW, LOT 2706701. AR-8735L-14, LOW PROFILE LOCKING SCREW, LOT 2706691.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925930 2.4 X 18MM VAL SCREW, TI PLATE, FIXATION, BONE HRS ARTHREX, INC. 2.4 X 18MM VAL SCREW, TI W698661 00888867045613

    Patients

    Seq Age Sex Outcome Treatment
    1 Other