BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA INITIAL DRILL 1.5X15MM NONIRR

    MDR report key: 1881235 · Received October 6, 2010

    Report

    Report Number
    3005990499-2010-00021
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    September 21, 2010
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRIMA INITIAL DRILL WAS RETURNED FOR EVAL. THE EXAM OF THE DEVICE CONFIRMS THAT THE DRILL WAS FRACTURED INTO TWO PIECES. THE DRILL BROKE AT THE LASER MARK, PERPENDICULAR TO ITS AXIS NEAR THE TOP OF THE DRILL. THIS IS A KNOWN ISSUE DUE TO INHERENT NATURE OF BIT FUNCTIONALITY. BREAKAGE IS POSSIBLE, ESPECIALLY WHEN UTILIZED IN THE POSTERIOR ASPECT OF THE MOUTH, AND IS DUE TO THE EXTREME ANGLE AND HIGH DIRECTIONAL FORCES REQUIRED. THE KEYSTONE SURGICAL MANUAL RECOMMENDS DRILLS SHOULD BE REPLACED AFTER APPROX 20 USES (DEPENDING ON BONE DENSITY). COMPLAINT CONDITION IS CONFIRMED; HOWEVER, THIS IS A KNOWN FAILURE MODE. ROOT CAUSE IS ATTRIBUTED TO OPERATIONAL CONTEXT. NO ADVERSE TRENDS NOTED. THIS PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON-STERILE DEVICE, CONSEQUENTLY, THERE IS NO EXPIRATION DATE. ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO. A FOLLOW-UP MEDWATCH FORM WILL BE SUBMITTED IF ADD'L INFO IS RECEIVED AT A LATER DATE. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE PRIMA INITIAL DRILL BROKE (DATE OF EVENT UNK). THERE WAS NO INDICATION FROM THE COMPLAINANT OF ANY ADVERSE EFFECT TO THE PT AS A RESULT OF THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMA INITIAL DRILL 1.5X15MM NONIRR NDP KEYSTONE DENTAL 15200K MM00364

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK