BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFTY TIGHTY LAG SCREW Ø10.5 MM X 85MM

    MDR report key: 19403863 · Received May 28, 2024

    Report

    Report Number
    1220246-2024-04013
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    April 29, 2024
    Report Date
    July 2, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    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

    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 04/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-085 TELESCOPING LAG SCREW LEFT UNTHREADED INTRAOPERATIVELY. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624283 LEFTY TIGHTY LAG SCREW Ø10.5 MM X 85MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ARTHREX, INC. LEFTY TIGHTY LAG SCREW Ø10.5 MM X 85MM 220955 00848665036527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown