BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL

    MDR report key: 22133158 · Received June 3, 2025

    Report

    Report Number
    1220246-2025-02349
    Event Type
    Malfunction
    Date Received
    June 3, 2025
    Date of Event
    May 8, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867313231
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: B5, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED BY THE ATTACHED PICTURE, WHICH SHOWS ONLY THE SCREWS HEADS THAT WERE BROKEN BETWEEN THE SHAFT AND HEAD. IT WAS OBSERVED THAT THE HEX OF THE HEAD WAS BENT, CHIPPED, AND BROKEN AROUND THE EDGES. 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 IS ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD, MISALIGNED INSERTION, OR PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 05/12/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN (QTY. 2) OF AN AR-18716-11 LOW PROFILE CORTICAL SCREW AND AN AR-18716V-12 VAL SCREW BROKE OFF DURING IMPLANTATION OF THE SCREW INTO A PLATE. EACH SCREW BROKE AT THE NECK WHILE THEY WERE SCREWING INTO THE PLATE, LEAVING THE SHAFT OF THE SCREW IN THE BONE, AS REMOVAL COULD NOT BE EXTRACTED. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE ORIF PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 06/02/2025.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: THE PLATE USED IN THE SURGERY WAS AR-18716P-12 Y-PLATE. THERE WERE NO DIFFICULTIES ENCOUNTERED WHEN SECURING SCREWS AND THE SURGEON DID NOT APPEAR TO BE OVER-TORQUING ON SCREWS BEFORE THE HEADS BROKE. ALL SCREW HEADS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED USING ADDITIONAL VAL SCREWS FROM THE MINI CFS SET, AR-18716V-11, -12, -13 AND AN EXTRA PLATE, AR-18716P-18 T-PLATE ON A SECOND FINGER THAT THEY DID NOT ENCOUNTER ANY ISSUES WITH. NO PIECE OF THE INSTRUMENT BROKE WHEN THE SCREWS BROKE OFF. THERE WAS NO CASE DELAY, AND NO ADDED ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS REPORTED ON OR AFTER THE SURGERY. THERE IS NO OTHER SURGERY PLANNED DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065546 LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL BONE FIXATION PLATE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL UNK 00888867313231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown