BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION TOOL

    MDR report key: 19818654 · Received July 24, 2024

    Report

    Report Number
    1220246-2024-06883
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665002607
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 0804-000 BATCH 211858 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. VISUAL INSPECTION REVEALED THAT THE SHAFT HAS A SIGNIFICANT BEND, COMPROMISING THE DEVICE'S PROPER FUNCTIONALITY. THE MOST PROBABLE CAUSE OF THE REPORTED AND OBSERVED FAILURE IS THE APPLICATION OF EXCESSIVE FORCE DURING USE.

    Description of Event or Problem · 0

    ON 06/28/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT A 0804-000 REDUCTION TOOL WAS BENT. THE SURGEON NOTICED THAT THE REDUCTION TOOL THEY WERE USING TO CHANGE THE POSITION OF THE BALL TIP WIRE WAS BENT AND SHOULD REMAIN STRAIGHT AND NOT BE EASY TO BEND IN THE SHAFT. THE REPRESENTATIVE STATED THAT THIS IS AN EXTENSIVE MANUAL FOR SURGEONS TO USE INTRAMEDULLARY, AND ANY BEND IN POOR BONE COULD CAUSE AN IATROGENIC FRACTURE. NO HARM CAME TO THE PATIENT; THEY CHANGED INSTRUMENTS WHEN THEY NOTICED THE DEFICIENCY IN THE PRODUCT. THIS WAS DISCOVERED DURING A HIP FRACTURE PROCEDURE (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358066 REDUCTION TOOL INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. REDUCTION TOOL 211858 00848665002607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown