BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR PAD, LONG

    MDR report key: 19404987 · Received May 28, 2024

    Report

    Report Number
    1220246-2024-04048
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    October 25, 2022
    Report Date
    May 28, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED 0835-000 SERIAL/BATCH NUMBER 180798 WAS RECEIVED FOR INVESTIGATION. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND IT WAS FOUND THAT THE CONNECTOR HOLE HAD A PIECE OF A PART INSIDE. MANY SCRATCHES WERE NOTED ON THE BODY OF THE DEVICE. NO FUNCTIONAL TEST CAN BE PERFORMED DUE TO THE OBSTRUCTION ON THE CONNECTOR HOLE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS USER ERROR FOR APPLYING EXCESSIVE FORCE DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 10/25/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN 0835-000 IMPACTOR PADS THREADS BROKE OFF IN THE 1280-000 TARGETING GUIDE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688577 IMPACTOR PAD, LONG ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. IMPACTOR PAD, LONG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown