BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY MAYO CLASSIC®

    MDR report key: 22505785 · Received July 15, 2025

    Report

    Report Number
    22505785
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 25, 2025
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    HXK
    UDI-DI
    00887482009710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A NEEDLE DRIVER WAS FOUND IN STERILE PROCESSING TO BE MISSING A LAYER OF THE INNER TIP. THE INSTRUMENT WAS PULLED FROM SERVICE. THE QUALITY ASSURANCE TEAM CONNECTED AND CONFIRMED THE RESULTS OF THE PATHOLOGY SPECIMEN, A 1 MM X ~2 MM METALLIC FLAKE OF A TEXTURED GRIPPING SURFACE, TO THE SEQUESTERED NEEDLE DRIVER. THIS METAL FLECK WAS IN THE PATIENT IN THE WOUND, FOUND ON ROUTINE POST OPERATIVE XRAY, LIKELY BROKE OFF DURING SUTURING/CLOSING THE WOUND. THE NEEDLE DRIVER/HOLDER WAS STILL FUNCTIONAL, AND THE BROKEN OFF FLECK WAS SO SMALL, IT WAS NOT IDENTIFIED AT TIME OF USE ON THE PATIENT. THE PATIENT DID RETURN TO THE OR FOR REMOVAL OF THE FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159734 SYMMETRY MAYO CLASSIC® HOLDER, NEEDLE; ORTHOPEDIC HXK SYMMETRY SURGICAL INC. 36-2017 31081195 00887482009710

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other| R