BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX

    MDR report key: 11723451 · Received April 26, 2021

    Report

    Report Number
    11723451
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 20, 2021
    Manufacturer
    SMITH NEPHEW, INC.
    Product Code
    GFG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SMITH AND NEPHEW NON IMPLANTABLE PRODUCT BROKE INSIDE A PATIENT DURING A ROUTINE RIGHT ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR WITH AUTOGRAFT. PRODUCT WAS ACUFEX TRUNAV RETROGRADE DRILL, 7.5MM. THE DEVICE AND PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT AND COMPARED TO IDENTICAL PRODUCT FOR CONFIRMATION BETWEEN SURGEON, NURSE AND TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623310 ACUFEX BIT, SURGICAL GFG SMITH NEPHEW, INC. 72204041 5045355

    Patients

    Seq Age Sex Outcome Treatment
    1 5475 DA