BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMA INITIAL DRILL 1.5 X 15MM NON-IRRIGATED

    MDR report key: 2180718 · Received May 5, 2011

    Report

    Report Number
    3005990499-2011-00016
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Report Date
    April 8, 2011
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NDP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALS THE DRILL IS BROKEN IN TWO PIECES. THERE WAS NO EVIDENCE OF RUST OBSERVED ON EITHER PORTION OF THE DRILL. THE DRILL APPEARED TO HAVE BEEN USED, AND THE TIP WAS DULL. THE DRILL BROKE AT THE LASER MARK, PERPENDICULAR TO ITS AXIS NEAR THE TOP OF THE DRILL. THIS IS A KNOWN ISSUE DUE TO THE INHERENT NATURE OF BIT FUNCTIONALITY. THE CUSTOMER WAS UNABLE TO REPORT THE LOT NUMBER OF THE DRILL AT ISSUE IN THIS COMPLAINT, BUT A SEARCH OF THIS CUSTOMER'S ORDERS REVEALED THAT THE LAST TIME THIS DEVICE KIT WAS ORDERED WAS ON 02/02/2009, TWO YEARS PRIOR TO THIS REPORTED PROBLEM OCCURRING. THE IMPLANT SITE NUMBER IS NOT KNOWN, BUT BREAKAGE IS POSSIBLE, ESPECIALLY WHEN UTILIZED IN THE POSTERIOR ASPECT OF THE MOUTH, AND IS DUE TO EXTREME ANGLE AND HIGH DIRECTION FORCES. THE COMPLAINT CONDITION IS CONFIRMED AND THIS IS A KNOWN FAILURE MODE. THE TOOTH SITE NUMBER IS NOT KNOWN, HOWEVER; ROOT CAUSE COULD BE ATTRIBUTED TO OPERATIONAL CONTEXT. KEYSTONE DENTAL'S SURGICAL MANUAL RECOMMENDS DRILLS BE REPLACED WHEN WORN, CORRODED, DULL OR OTHERWISE COMPROMISED. FURTHERMORE, THE MANUAL RECOMMENDS THAT DRILLS SHOULD BE REPLACED AFTER APPROX TWENTY (20) USES DEPENDING ON BONE DENSITY. THE LOT NUMBER OF THE DEVICE AT ISSUE IN THIS COMPLAINT WAS NOT REPORTED; THEREFORE, THE MANUFACTURE DATE OF THE DEVICE IS UNK. THIS PRODUCT IS SUPPLIED BY KEYSTONE DENTAL AS A NON-STERILE DEVICE, CONSEQUENTLY, THERE IS NO EXPIRATION DATE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFO. A F/U MEDWATCH FORM WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED AT A LATER DATE. KEYSTONE DENTAL REFERENCE: COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIAN WAS PERFORMING A DENTAL PROCEDURE ON A PT USING A PRIMA INITIAL DRILL WHEN THE DRILL FRACTURED (DATE OF FRACTURE UNK). THERE WAS NO INDICATION FROM THE COMPLAINANT OF ANY ADVERSE EFFECT TO THE PT AS A RESULT OF THE REPORTED DRILL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMA INITIAL DRILL 1.5 X 15MM NON-IRRIGATED NDP KEYSTONE DENTAL 15200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK