BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION TORQUE PUSH BUTTON BUR CHANGING

    MDR report key: 1674540 · Received April 28, 2010

    Report

    Report Number
    2916440-2010-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    September 1, 2009
    Report Date
    September 10, 2009
    Manufacturer
    LARES RESEARCH INC.
    Product Code
    EFB
    PMA / PMN Number
    K780038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE CONDITIONS OF PRODUCT (SN (B)(4), MFG DATE 07-2009) WERE OBSERVED: FRONT BEARING SHIELD WAS DISLODGED AND LOOSE INSIDE THE HEAD OF THE HANDPIECE. PUSH BUTTON CHUCK HAD SLIPPED ON BUR SHANK REMOVING MATERIAL. PUSH BUTTON HAD DISLODGED FROM THE HEAD CAP. THE HEAD CAP WAS SECURELY TIGHTENED ONTO THE HEAD OF HANDPIECE. DETAILED MEASUREMENT AND INSPECTION OF BUTTON RETENTION CROWN IDENTIFIED FORM AND SHAPE IN-LINE WITH INCOMPLETE FORMING (DURING ASSEMBLY). CONCLUSION: MARKINGS ON THE INSIDE OF THE BUTTON INDICATE DYNAMIC CONTACT WITH CHUCK WHICH TRANSFERRED ENOUGH FORCE TO DISLODGE THE MARGINALLY RETAINED BUTTON. CONTACT WAS CAUSED BY INADVERTENT DEPRESSION OF THE BUTTON DURING USE WHICH WAS COMPOUNDED BY THE BUR SHANK WEAR (MATERIAL LOSS) AND THE BEARING SHIELD DISLODGING. BUR SHANK WEAR DECREASES CLEARANCE BETWEEN THE BUTTON AND THE CHUCK AND THE SHIELD DISPLACEMENT REDUCED THE TURBINES AXIAL DEFLECTION ABILITY. ONE HUNDRED PERCENT OF ON HAND SUB ASSEMBLY INVENTORY WAS INSPECTED AND (B)(4) NON CONFORMING COMPONENTS WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE PUSH BUTTON FELL OUT OF THE HANDPIECE INTO THE PT'S MOUTH. PT DID NOT NEED MEDICAL TREATMENT. NO DETERMINATION OF THE PT WAS MALE OR FEMALE. AGE OF THE PT WAS NOT DETERMINED. NO MEDICAL ATTENTION FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION TORQUE PUSH BUTTON BUR CHANGING HIGH-SPEED DENTAL HANDPIECE EFB LARES RESEARCH INC. 330E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other