BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO SCRW TM,SS 3.5X 18MMCORT

    MDR report key: 18175227 · Received November 20, 2023

    Report

    Report Number
    1220246-2023-08826
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    September 13, 2023
    Report Date
    March 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047303
    PMA / PMN Number
    K203239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 DESCRIPTIONS, 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 MISUSE OF THE PRODUCT, CAUSED BY THE SURGEON USING EXCESSIVE FORCE AND DAMAGING THE HEAD OF THE SCREW. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE FAILURE WAS PROVIDED.

    Description of Event or Problem · 0

    ON 10/27/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8835-18 LOW PROFILE SCREW HEAD BROKE OFF DURING INSERTION. THE BODY OF THE SCREW WAS LEFT IMPLANTED AND THE HEAD WAS REMOVED. THIS WAS DISCOVERED DURING AN ORIF OF THE RIGHT CLAVICLE PROCEDURE ON 9/13/2023. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855337 LO-PRO SCRW TM,SS 3.5X 18MMCORT BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 18MMCORT UNK 00888867047303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown