BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLVE INSTRUMENT GRAPHIC CASE

    MDR report key: 2079626 · Received April 5, 2011

    Report

    Report Number
    3004142400-2011-00004
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS RETURNED FOR EVALUATION AND A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTIONS OF THE PRODUCT USED WITH THE CONCOMITANT DEVICE. ALL RECORDS REVEALED ALL PRODUCT LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED, AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. BASED ON RECORD REVIEW OF ALL AVAILABLE INFORMATION AND EVALUATION OF THE PRODUCT IN QUESTION, IT IS DETERMINED THE REVOLVE INSTRUMENT GRAPHIC CASE DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS. THERE IS NO INDICATION THAT THE ISSUE WAS A RESULT OF PRODUCT DEFECT.

    Description of Event or Problem · 1

    GLOBUS MEDICAL, INC WAS CONTACTED VIA TELEPHONE COMMUNICATION FROM A SALES REPRESENTATIVE THAT ON (B)(6) 2010 A MALE SCRUB TECHNICIAN AT THE HOSPITAL FACILITY SUSTAINED AN INJURY TO HIS FOOT WHEN A HANDLE BROKE OFF THE REVOLVE GRAPHIC CASE HE WAS CARRYING, AND THE CASE CONTAINING REVOLVE SURGICAL INSTRUMENTS LANDED ON HIS FOOT AFTER WHICH HE EXPERIENCED PAIN AND SWELLING. THE SCRUB TECHNICIAN WENT TO THE HOSPITAL EMERGENCY ROOM FOR TREATMENT AND WAS DIAGNOSED WITH A CONTUSION AND SPRAIN ON THE TOP OF HIS RIGHT FOOT. THE SCRUB TECHNICIAN WAS OUT OF WORK ON WORKER'S COMPENSATION, AND HAS SINCE THEN RETURNED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLVE INSTRUMENT GRAPHIC CASE REVOLVE INSTRUMENT GRAPHIC CASE LXH GLOBUS MEDICAL, INC. 985.002 JEJ015BA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other REVOLVE SURGICAL INSTRUMENTS