BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOR DRIVE UNIT,ULTRALIGHT W/

    MDR report key: 4931842 · Received July 22, 2015

    Report

    Report Number
    1643264-2015-00044
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    April 19, 2013
    Report Date
    July 22, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED COMPLAINT. THE MOTOR ((B)(4)) STALLS AT LESS THAN 500 RPM. MOTOR HAS FAILED UNDER WARRANTY AND WILL BE RETURNED TO THE SUPPLIER. SMITH & NEPHEW WILL CONTINUE TO MONITOR FOR ANY FUTURE OCCURENCE OF THIS FAILURE TYPE. (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE THE MOTOR DRIVE UNIT, ULTRALIGHT W/ ELECTRICAL GETS HEATED WHEN USED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477059 MOTOR DRIVE UNIT,ULTRALIGHT W/ SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1