BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SURGICAL INC.

    MDR report key: 19632995 · Received June 28, 2024

    Report

    Report Number
    3007208013-2024-00031
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Report Date
    June 28, 2024
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    HXK
    UDI-DI
    00887482009888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED VIA MEDWATCH REPORT# MW5154902. THE INFORMATION WAS RECEIVED THROUGH THE FDA WITH NO CUSTOMER INFORMATION PROVIDED. AS SUCH, NO INVESTIGATION CAN BE COMPLETED, CONFIRMATION OF THE COMPLAINT IS UNDETERMINABLE, AND A TRUE ROOT CAUSE CAN NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.

    Description of Event or Problem · 0

    THE COMPLAINANT ALLEGES, "DURING NEEDLE DRIVER INSPECTION TO ASSESS FOR INSTRUMENT INTEGRITY PRIOR TO USE, THE NEEDLE DRIVER TIP WAS DETECTED TO BE BENT WITH A SMALL PORTION OF IT THAT BROKE OFF. THE NEEDLE DRIVER WAS NEVER UTILIZED DURING THE CASE AND IT ALONG WITH THE BROKE TIP WERE SUBSEQUENTLY SEQUESTERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215584 SYMMETRY SURGICAL INC. NEEDLE HOLDER HXK SYMMETRY SURGICAL INC. 36-3011 00887482009888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown