BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERMAX ELITE HANDPIECE

    MDR report key: 2863030 · Received December 10, 2012

    Report

    Report Number
    1643264-2012-00018
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PASSED FUNCTIONAL TESTING PER PROCESS SUMMARY (B)(4) REV W STEPS 9.1 THRU 9.1.6 AND HIGH SPEED (10,000 RPM) TESTING WITH BLADES INSTALLED. MDU DID NOT OVERHEAT OR LOCK UP DURING TESTING. NO PROBLEM FOUND AFTER EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY, PATIENT IN LATERAL DECUBITUS POSITION, SURGEON SWITCHED FROM A BLADE TO AN ELITE STONE CUTTER ((B)(4)). SALES REP COMMENTED THAT IT WAS NOT "SPINNING" FAST ENOUGH. REP HAD NO DETAIL ON RPMS. HE REMOVED THE BURR TO EXAMINE IT AND PLACED IT BACK IN THE MDU. MDU STARTED TO HEAT UP AND HE COULD NOT REMOVE THE BURR FROM THE HUB OF THE MDU. THEY ENDED UP UNPLUGGING THE MDU FROM THE DII UNIT TO STOP THE BURR. THEY DISCOVERED THE BURR WAS WELDED ONTO THE HUB. REP SAID THIS DR HAS BEEN A SURGEON FOR 25 YEARS AND THEY DID USE ADEQUATE IRRIGATION. WHEN THEY WERE CLOSING THEY NOTICED A RED MARK OVER THE DELTOID THE WIDTH OF THE MDU AND APPROXIMATELY 2-3" LONG ON THE PATIENT'S SHOULDER. WHEN SALES REP ARRIVED AT THE FACILITY, HE PLUGGED THE SUSPECT MDU INTO THE DII UNIT AND GOT A WARNING -"SHORT-CIRCUIT DETECTED" ERROR. HE THEN TOOK HIS MDU AND PLUGGED IT INTO THE SAME DII UNIT AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERMAX ELITE HANDPIECE MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL HRX SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE 72200616

    Patients

    Seq Age Sex Outcome Treatment
    1