BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO SURGICAL SYSTEM

    MDR report key: 6513417 · Received April 21, 2017

    Report

    Report Number
    3010266064-2017-00010
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    February 20, 2017
    Report Date
    February 23, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES, INC.
    Product Code
    OLO
    PMA / PMN Number
    K160537
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED BY THE MANUFACTURER AND DETERMINED TO BE CONSISTENT WITH THE CURRENTLY FILED BUG 1093. SMITH & NEPHEW HAS RE-ASSESSED THIS COMPLAINT IN ACCORDANCE TO THE PROVISIONS OF 21 C.F.R. §803.50 AND DEEMED THIS EVENT REPORTABLE AS A MDR REPORTABLE EVENT. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A. DISCLAIMER: SMITH & NEPHEW IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. CORRECTION: B1 AND H1 WERE UPDATED TO REPORT TYPE ADVERSE EVENT. CORRECTION: B5 WAS UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING BONE PIN PLACEMENT, THE TISSUE PROTECTOR GOT STUCK ON THE PIN. WE WERE ABLE TO REMOVE THE FRONT PIN AND SCREW THE STUCK PIN OUT OF THE BONE USING THE TISSUE PROTECTOR.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MANUFACTURER AND DETERMINED TO BE CONSISTENT WITH THE CURRENTLY FILED BUG 1093.

    Description of Event or Problem · 1

    DURING BONE PIN PLACEMENT, THE TISSUE PROTECTOR GOT STUCK ON THE PIN. WE WERE ABLE TO REMOVE THE FRONT PIN AND SCREW THE STUCK PIN OUT OF THE BONE USING THE TISSUE PROTECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292447 NAVIO SURGICAL SYSTEM NAVIO SURGICAL SYSTEM OLO BLUE BELT TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention