BEUDAMED
    FDA Adverse Event Summary report: N

    CLASSIC PLUS(R) STERNAL NEEDLE HOLDER

    MDR report key: 5100896 · Received September 15, 2015

    Report

    Report Number
    3007208013-2015-00020
    Date Received
    September 15, 2015
    Date of Event
    August 3, 2015
    Report Date
    September 8, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    HXK
    UDI-DI
    00887482009772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEEDLE INSERT CAME APART AND FELL INSIDE THE PATIENT. NO HARM TO THE PATIENT. THE NEEDLE HOLDER INSERTS WERE INSPECTED ON DEVICES FROM ALL LOTS IN INVENTORY. THERE WERE NO ISSUES WITH THE INSERTS FOUND. THIS DEVICE WAS MANUFACTURED IN (B)(6) 2011. THE INSERTS WERE REPAIRED UNDER WARRANTY. THE DEVICE IS BEING REPAIRED AND RETURNED TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    NEEDLE INSERT CAME APART AND FELL INSIDE THE PATIENT. NO HARM TO PATIENT. DEVICE WAS MANUFACTURED IN (B)(6) 2011. THE INSERTS WERE REPAIRED UNDER WARRANTY IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610698 CLASSIC PLUS(R) STERNAL NEEDLE HOLDER NEEDLE HOLDER HXK SYMMETRY SURGICAL INC. 36-2025 00887482009772

    Patients

    Seq Age Sex Outcome Treatment
    1