BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFTY TIGHTY LAG SCREW, Ø10.5MM X 95MM

    MDR report key: 19023532 · Received April 2, 2024

    Report

    Report Number
    1220246-2024-01785
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 13, 2024
    Report Date
    June 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036541
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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 DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    ON 03/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN 1192-095 TELESCOPING LAG SCREW LEFT WOULD NOT ADVANCE INTO THE FEMORAL HEAD. THIS OCCURRED DURING AN IM NAIL HIP PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 3/18/2024: THE CASE WAS COMPLETED USING A RIGHT LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269940 LEFTY TIGHTY LAG SCREW, Ø10.5MM X 95MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MM X 95MM 212118 00848665036541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown