BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17190321 · Received June 23, 2023

    Report

    Report Number
    1220246-2023-06970
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 15, 2023
    Report Date
    October 31, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665036541
    PMA / PMN Number
    K202099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT WAS CONFIRMED. ONE UNPACKAGED 1192-095 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE THREAD WAS BROKEN/DAMAGED. THE REPORTED CONDITION IS MOST LIKELY CAUSED BY OVERSTRESSING A DEVICE. WHEN TWO DEVICES ARE INTENDED TO BE THREADED TOGETHER, ENSURE THAT THEY ARE FULLY ENGAGED PRIOR TO USE.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT HAS NOT YET BEEN DETERMINED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A MOST LIKELY CAUSE IF A ROOT CAUSE CAN NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON 6/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE THREADS OF AN 1192-095 LEFTY TIGHTY LAG SCREW BROKE. WHILE PASSING THE NAIL, THE THREADS OF THE LAG SCREW BROKE AND WERE RETRIEVED SUCCESSFULLY. THE CASE WAS COMPLETED WITH ANOTHER LAG SCREW. THIS WAS DISCOVERED DURING A TROCH NAIL PROCEDURE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855557 LEFTY TIGHTY LAG SCREW, Ø10.5MM X 95MM INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. LEFTY TIGHTY LAG SCREW, Ø10.5MM X 95MM 230093 00848665036541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown