BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGC TI HAND-HELD ROD CUTTER

    MDR report key: 5661394 · Received May 17, 2016

    Report

    Report Number
    3004485144-2016-00075
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 19, 2016
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    KWQ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE PRODUCT EVALUATION. DEVICE PRODUCT CODE IS FZT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXAMINED AND FOUND TO HAVE A WORN CUTTING SURFACE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT FIND ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THE ROD CUTTER TIP BROKE WHEN ATTEMPTING TO CUT A COBALT CHROME ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316942 NGC TI HAND-HELD ROD CUTTER ROD CUTTER KWQ BIOMET SPINE - BROOMFIELD N/A 021510

    Patients

    Seq Age Sex Outcome Treatment
    1