BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO SCRW,TI,3.5MMX 16MM

    MDR report key: 23192359 · Received October 1, 2025

    Report

    Report Number
    1220246-2025-04329
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 12, 2025
    Report Date
    November 10, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K203294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. PHOTOGRAPHIC EVIDENCE PROVIDED FROM THE FIELD OF AN AR-8935-16, WITH BATCH NUMBER 15452495, REVEALED THAT THE SCREW WAS DAMAGED. THEREFORE, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO PRYING/LEVERAGING THE SCREW DURING INSERTION. DFU-0125-EO REVISION 7: 4. DAMAGE TO THE DRIVER OR SCREW MAY RESULT FROM FAILURE TO SEAT THE DRIVER FULLY INTO THE SCREW OR TO ALIGN THE DRIVER PROPERLY WITH THE SCREW. USE SOLID DRIVER AS OPPOSED TO A CANNULATED DRIVER FOR SCREW REMOVAL.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 09/15/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT DURING AN ANKLE FRACTURE PROCEDURE PERFORMED ON (B)(6) 2025, THE HEAD OF AN AR-8935-16 NON-LOCKING LOW PROFILE SCREW BROKE OFF WHILE BEING INSERTED INTO A PLATE. THE SURGEON ELECTED TO LEAVE THE HEADLESS SCREW IN PLACE AND PROCEEDED WITH THE PROCEDURE. THE DETACHED PORTION OF THE SCREW WAS NOT LOCATED OR REMOVED. ADDITIONAL INFORMATION WAS RECEIVED ON 09/19/2025: THE HEAD OF THE SCREW BROKE OFF WHILE BEING INSERTED INTO AN AR-9943T-10 LOCKING THIRD TUBULAR PLATE, 10 HOLE. THE NURSE SET ASIDE THE BROKEN SCREW HEAD, AND THE SURGEON PROCEEDED WITH THE PROCEDURE BY USING THE NEXT HOLE IN THE PLATE, LEAVING THE BROKEN HEADLESS SCREW IN PLACE. THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. AN AR-8943-30 DRILL BIT, 2.5 MM, WAS USED TO PREPARE THE BONE SOCKET FOR IMPLANT INSERTION. THE PATIENT'S BONE QUALITY WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105828 LO-PRO SCRW,TI,3.5MMX 16MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 16MM 15452495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown