BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SVC REPL,MDU, HAND CNTRL, PWRMX

    MDR report key: 6078581 · Received November 4, 2016

    Report

    Report Number
    1643264-2016-00209
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .H3: DEVICE INVESTIGATION NARRATIVE - ONE SERVICE REPLACEMENT POWERMAX ELITE MOTOR DRIVE UNIT, PART NUMBER 72200616S WAS RECEIVED ON OCTOBER 27, 2016 AND CONFIRMED TO BE SERIAL NUMBER AAL44570 AS REPORTED IN THE COMPLAINT. THE REPORTED COMPLAINT OF OVERHEATING AND MOTOR STALL COULD NOT BE CONFIRMED. PRODUCT DID NOT OVERHEAT DURING FUNCTIONAL TESTING. UNIT WAS TESTED AT SPEED SETTINGS OF BETWEEN 500 AND 10,000 RPMS IN FORWARD AND REVERSE FOR 5 MINUTES EACH. THE OSCILLATE FUNCTION WAS TESTED FOR 5 MINUTES OF CONTINUOUS PERFORMANCE WITH NO OVERHEATING. TEST BLADE DID NOT MELT AT HIGH SPEEDS WHEN USED CORRECTLY WITH IRRIGATION. PRODUCT WAS TESTED ON A KNOWN GOOD DYONICS POWER, DII, AND DII EIP CONTROL UNITS WITH AND WITHOUT FOOTSWITCH. AT NO TIME DID MDU OVERHEAT OR LOCK UP. ALL FUNCTIONS PERFORM AS EXPECTED. NO PROBLEM FOUND.C-0123748

    Description of Event or Problem · 1

    IT WAS REPORTED THE MOTOR DRIVE UNIT HAND CNTRL PWRMX EL WAS NOT TURNING AND OVERHEATED DURING USE. THIS OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH SAME DEVICE. THERE WAS NO DELAY OR PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730794 SVC REPL,MDU, HAND CNTRL, PWRMX SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1