BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM INCISOR PLUS PLATINUM BLADE

    MDR report key: 6141245 · Received December 2, 2016

    Report

    Report Number
    1219602-2016-01295
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION NARRATIVE - ONE 4.5 MM INCISOR PLUS PLATINUM BLADE WAS RECEIVED FOR EVALUATION. FUNCTIONAL INSPECTION WAS PERFORMED AND THE INNER BLADE ROTATED FREELY WITHIN THE OUTER BLADE, NO FRICTION WAS FELT IN THE UNLOADED CONDITION. NO CONTAMINATION OF ANY KIND WAS OBSERVED ON THE RETURNED BLADE. THIS BLADE WAS SENT IN CONJUNCTION WITH AN MDU THAT WAS EXPERIENCING OVERHEATING ISSUES. THE MDU AND BLADE WERE TESTED IN OKC THE FOLLOWING OBSERVATIONS WERE MADE DURING THIS TESTING. ONE SERVICE REPLACEMENT POWERMAX ELITE MOTOR DRIVE UNIT, PART NUMBER 72200616S (SERIAL NUMBER (B)(4)) AND ONE 4.5 MM INCISOR PLUS PLATINUM BLADE WERE RECEIVED. THE REPORTED COMPLAINT OF OVERHEATING COULD NOT BE CONFIRMED. THE MDU WAS NOT BURNED OUT, NOR DID IT OVERHEAT DURING FUNCTIONAL TESTING. UNIT WAS TESTED AT SPEED SETTINGS OF BETWEEN 500 AND 10,000 RPMS IN FORWARD AND REVERSE. THE OSCILLATE FUNCTION WAS TESTED FOR 5 MINUTES OF CONTINUOUS PERFORMANCE WITH NO OVERHEATING. TEST BLADE DID NOT MELT 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK SOOT CAME OUT NEAR THE BLADE. ALL SOOT WAS REMOVED FROM THE PATIENT. A SHORT DELAY WAS REPORTED WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793910 4.5MM INCISOR PLUS PLATINUM BLADE SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1