BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL (DISPOSABLE) 2.75MM X 15MM

    MDR report key: 855310 · Received May 23, 2007

    Report

    Report Number
    1038806-2007-00002
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Report Date
    May 1, 2007
    Manufacturer
    BIOMET 3I, INC.
    Product Code
    ERL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD COMPLAINT WAS REPORTED BY AN INTERNATIONAL DIST ONLY - NO DOMESTIC COMPLAINTS FOR THIS PROBLEM HAVE BEEN REPORTED. THE MFG LOT OF DRILLS WITH THE PROBLEM LOT # 622762 WERE PACKAGED INTO 2 PACKAGING LOTS # 635699 AND # 652460 FOR A TOTAL OF UNITS RECALLED.

    Description of Event or Problem · 1

    DISPOSABLE TWIST DRILLS REC'D BY IMPLANT FACILITY WERE INSPECTED BY THE DIST AND REJECTED. THE TWIST DRILLS HAVE LASER MARKED DEPTH INDICATORS THAT ARE USED BY CLINICIANS TO MEASURE THE OSTEOTOMY DEPTH FOR DENTAL IMPLANT PLACEMENT. THESE LASER MARKINGS ARE FADED AND WOULD BE DIFFICULT TO READ DURING A SURGICAL PROCEDURE. TEN UNITS FROM PACKAGING LOT 635699 WERE RETURNED UNOPENED TO BIOMET 3I. UPON VISUAL EXAMINATION BY BIOMET 3I, IT WAS DETERMINED THAT THE LASER MARKINGS DID NOT MEET MFG VISUAL STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIST DRILL (DISPOSABLE) 2.75MM X 15MM TWIST DRILL ERL BIOMET 3I, INC. 635699

    Patients

    Seq Age Sex Outcome Treatment
    1 YR