BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURB, 3RD ED., C/U, S&N DYONICS 25

    MDR report key: 6207065 · Received December 27, 2016

    Report

    Report Number
    1643264-2016-00311
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    PMA / PMN Number
    K051326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - COMPLAINT OF PRESSURE MALFUNCTION COULD NOT BE REPRODUCED. PRODUCT PASSED FUNCTIONAL TESTING WITH NO FAULTS OR ERRORS. PRODUCT PASSED FUNCTIONAL TESTING DURING 4 HOUR BURN-IN ON WET STATION UTILIZING LOW AND HIGH PRESSURE AND FLOW SETTINGS. RAW AND ZERO TRANSDUCER READINGS WERE NORMAL AND WELL WITHIN SPECS DURING ALL FUNCTIONAL TESTS. NO OVER PRESSURIZATION OR ERRORS OCCURRED DURING FUNCTIONAL TESTING OR BURN-IN. PLEASE REFER TO THE OPERATIONS/SERVICE MANUAL (PART NUMBER 1061600) FOR TROUBLESHOOTING GUIDANCE IF POOR OR ERRATIC PRESSURE PERFORMANCE IS OBSERVED. A REVIEW OF THE SERVICE DEVICE HISTORY RECORD SHOWS THAT THIS UNIT PASSED ALL ACCEPTANCE CRITERIA AND WAS COMPLIANT UPON RELEASE FOR DISTRIBUTION ON OR ABOUT OCTOBER 10, 2016. THERE ARE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION WHEN RELEASED TO DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE REFURB 3RD ED. C/U S&N DYONICS 25 PUMP WAS RUNNING OVER. THIS OCCURRED DURING THE PROCEDURE. A BACKUP DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THERE WERE NO DELAYS OR PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857707 REFURB, 3RD ED., C/U, S&N DYONICS 25 ARTHROSCOPE HRX SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR