BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL SURGICAL INSTRUMENT

    MDR report key: 3982948 · Received July 2, 2014

    Report

    Report Number
    3004485144-2014-00009
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    HTF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE TIP OF AN ANGLED CURETTE BROKE OFF. AFTER TRYING TO REMOVE THE PIECE FROM THE PATIENT FOR 30 MINUTES, THE SURGEON DECIDED TO LEAVE THE FRAGMENT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT HAS SHOWN NO ADVERSE EFFECTS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388837 MANUAL SURGICAL INSTRUMENT CURETTE HTF BIOMET SPINE LLC 2200-1004 LX-1170

    Patients

    Seq Age Sex Outcome Treatment
    1