BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFB DYO PWRMINI HAND CONTROLS

    MDR report key: 7145495 · Received December 26, 2017

    Report

    Report Number
    1643264-2017-01850
    Event Type
    Malfunction
    Date Received
    December 26, 2017
    Date of Event
    December 6, 2017
    Report Date
    January 31, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND NO ISSUE WAS OBSERVED. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. PRODUCT FAILED FUNCTIONAL TESTING WITH MOTOR STALL ERROR AND OVERHEATING. CAUSE OF OVERHEATING AND ERRORS IS A CORRODED MOTOR/GEARBOX. THE MOTOR/GEARBOX ASSEMBLY WAS REMOVED FROM THE HOUSING AND THE GEARBOX WAS REMOVED FROM THE MOTOR. THE GEARBOX WAS FOUND TO BE JAMMED. THE MOTOR PASSED FUNCTIONAL TESTING. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE HAS BEEN DETERMINED TO BE CORROSION OF THE GEARBOX ASSEMBLY. A MOTOR STALL CONDITION WILL RESULT IN INCREASED CURRENT DRAW FROM THE CONTROL UNIT WHICH WILL HEAT THE MOTOR AND HAND PIECE HOUSING. FACTORS WHICH CAN CONTRIBUTE TO GEARBOX CORROSION INCLUDE CLEANING AND STERILIZATION METHODS AND THE CHEMICALS INVOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A CORRECTIVE ACTION HAS BEEN INITIATED TO MITIGATE FUTURE RECURRENCE OF SIMILAR EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE WILL NOT ROTATE THE BLADE AND THE MOTOR OVERHEATS QUICKLY. NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924922 RFB DYO PWRMINI HAND CONTROLS SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1