BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM

    MDR report key: 18192567 · Received November 22, 2023

    Report

    Report Number
    1220246-2023-08887
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 27, 2023
    Report Date
    October 28, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION WAS 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 IMPROPER BONE PREP, MISALIGNED INSERTION.

    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.

    Description of Event or Problem · 0

    ON 10/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-110 TELESCOPING LAG SCREW LEFT COLLAPSED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668525 LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MM X 110MM 212132 00848665036572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown