BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SHARP KERRISON

    MDR report key: 5008394 · Received August 12, 2015

    Report

    Report Number
    3007208013-2015-00016
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    June 10, 2015
    Report Date
    August 11, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SALE REPRESENTATIVE, THE SURGEON WAS CUTTING CORTICAL BONE AND TWISTING THE INSTRUMENT, SALES REP STATED: (THE SURGEON) THIS IS HOW HE USES ALL OF HIS KERRISONS. THIS IS THE ONLY OCCURRENCE OF THE LOCKS BREAKING IN THIS MANNER. ITEMS IN INVENTORY ARE FUNCTIONING AS INTENDED. THE MATERIALS HAVE NOT CHANGED AND THEIR FUNCTIONALITY HAS NOT CHANGED.

    Description of Event or Problem · 1

    DOCTOR TRIED TO TAKE TOO BIG OF A BITE OF BONE AND LOCKING MECHANISM BROKE. LUMBAR FUSION PROCEDURE, NO DELAY IN TREATMENT, NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531187 SYMMETRY SHARP KERRISON SHARP KERRISON HANDLE HAE SYMMETRY SURGICAL INC. 53-1675 53-1675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other