BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 22149529 · Received June 5, 2025

    Report

    Report Number
    1220246-2025-02387
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 14, 2025
    Report Date
    October 8, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. 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 OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR IN THE DEVICE, WHICH IS RELATED TO NOT FOLLOWING THE INSTRUCTIONS THAT THE MINI CFS SCREWS ARE TO BE USED WITH THE ARTHREX MINI CFS PLATES (1.4-1.6 MM). DFU-0125-EO B. INDICATIONS - THE ARTHREX MINI CFS SCREWS (1.4-1.6 MM SOLID) ARE INTENDED FOR USE IN SELECTIVE TRAUMA, RECONSTRUCTIVE PROCEDURES, AND GENERAL SURGERY OF THE HAND, WRIST, AND OTHER SMALL BONES. THE MINI CFS SCREWS ARE TO BE USED WITH THE ARTHREX MINI CFS PLATES (1.4-1.6 MM).

    Description of Event or Problem · 0

    ON 5/16/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT QTY. 2 OF AN AR-18714V-09 VAL SCREW, 1.4 MM X 9 MM, HAD AN ISSUE DURING A METACARPAL FRACTURE REPAIR PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS TRYING TO INSERT TWO OF THOSE SCREWS INTO THE LOCKING PLATE, BOTH SCREWS WOULD NOT LOCK INTO THE LOCKING PLATE. BOTH SCREWS WERE REMOVED IN ONE PIECE FROM THE PATIENT, NOTHING BROKE, AND THERE WAS NO HARM. AN AR-18714-09 CORTICAL SCREW, 1.4 MM X 9 MM WITH AN UNKNOWN LOT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE COMPLAINT DEVICES WERE AVAILABLE FOR RETURN. THERE WAS NO CASE DELAY REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80421 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown