BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO SCRW TM,SS 3.5X 60MMCORT

    MDR report key: 16303294 · Received February 6, 2023

    Report

    Report Number
    1220246-2023-06237
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    December 14, 2022
    Report Date
    August 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867047501
    PMA / PMN Number
    K203239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    COMPLAINT ALLEGATION IS NOT CONFIRMED. 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 MISALIGNED INSERTION AND/OR EXCESSIVE FORCE BEING USED DURING INSERTION OF THE SCREW.

    Description of Event or Problem · 0

    ON 1/17/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH EMAIL THAT AN AR-8835-60 LOW PROFILE SCREW HEAD BROKE DURING THE PROCEDURE ON (B)(6) 2022. THE BODY OF THE SCREW REMAINS IN THE PATIENT AND BROKEN HEAD WAS RETRIEVED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99801 LO-PRO SCRW TM,SS 3.5X 60MMCORT SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 60MMCORT 1229434 00888867047501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown