BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO SCRW,TI,3.5MMX 14MM

    MDR report key: 18942596 · Received March 20, 2024

    Report

    Report Number
    1220246-2024-01564
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    February 21, 2024
    Report Date
    June 4, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867050402
    PMA / PMN Number
    K203294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE BEING USED DURING INSERTION OF THE SCREW.

    Description of Event or Problem · 0

    ON 03/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8935-14 LOW PROFILE SCREWS HEAD BROKE OFF. THIS OCCURRED DURING AN ANKLE FRACTURE ON 02/21/2024. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2024, WHERE THE SALES REPRESENTATIVE REPORTED THAT THE SCREW HEAD BROKE OFF DURING INSERTION, AND THE SHAFT OF THE SCREW REMAINS IN THE PATIENT. AN AR-8943-30 WAS USED TO PREPARE THE BONE, AND THE PATIENT HAD A VERY HARD BONE. A LONGER TI 1/3 TUBULAR PLATE AND SCREWS WERE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130531 LO-PRO SCRW,TI,3.5MMX 14MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 14MM 15145603 00888867050402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown