BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL

    MDR report key: 22719822 · Received August 5, 2025

    Report

    Report Number
    1220246-2025-03256
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 11, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867313231
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. THE FAILED DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING EXCESSIVE TORQUE APPLIED DURING EXTRACTION AND/OR IMPROPER REMOVAL TECHNIQUE, OR INCORRECT TOOLS. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON THE CUSTOMER'S ATTACHED PICTURE, WHERE THE HEAD OF THE SCREW WAS OBSERVED.

    Description of Event or Problem · 0

    ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-18716-11 CORTICAL SCREW BROKE DURING REMOVAL. AFTER PLACING ALL SCREWS AND A PLATE, THE CONSTRUCT WAS EVALUATED VIA X-RAY, AND IT WAS DETERMINED THAT THE 11 MM SCREW WAS TOO LONG. THE SURGEON ATTEMPTED TO BACK OUT THE SCREW TO REPLACE IT WITH A SHORTER ONE, BUT THE SCREW FRACTURED DURING REMOVAL. THE BREAK OCCURRED BELOW THE PLATE, MAKING REMOVAL NOT FEASIBLE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THIS OCCURRED DURING A METACARPAL ORIF PROCEDURE. AN AR-18716P-18 T-PLATE (LOT 105642321) WAS SUCCESSFULLY IMPLANTED. NO DAMAGE HAPPENED TO THE PLATE, AND NO SURGICAL INSTRUMENTS BROKE DURING REMOVAL. HOWEVER, ONE AR-18716-11 CORTICAL SCREW FRACTURED AND REMAINED IN THE BONE. THE CORRECT DRIVER WAS USED CONSISTENTLY THROUGHOUT THE PROCEDURE AND FUNCTIONED PROPERLY ON THE REMAINING SIX SCREWS. THE LOT NUMBER FOR THE BROKEN SCREW IS UNKNOWN. THERE WAS NO CHANGE IN SURGICAL TECHNIQUE, AND NO ADDITIONAL PRODUCTS WERE USED TO COMPLETE THE CASE. A DELAY OF APPROXIMATELY FIVE MINUTES OCCURRED, BUT NO EXTRA ANESTHESIA WAS ADMINISTERED. THE AR-18700-12 DRILL BIT WAS USED TO PREPARE THE BONE SOCKET FOR IMPLANT PLACEMENT, WITH THE BONE QUALITY ASSESSED AS AVERAGE. NO MEDICAL INTERVENTION HAS BEEN REQUIRED POSTOPERATIVELY. IT REMAINS UNDETERMINED WHETHER THE RETAINED SCREW WILL CAUSE ANY ADVERSE OUTCOMES OR REQUIRE FUTURE SURGICAL INTERVENTION. THE PATIENT WAS DISCHARGED TO POSTOPERATIVE CARE. ADDITIONAL INFORMATION WAS RECEIVED ON 08/01/2025: THIS OCCURRED ON (B)(6) 2025 FOR A METACARPAL ORIF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497811 LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL BONE FIXATION SCREW/PLATE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL UNK 00888867313231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown