BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.5 L125 2FLUTE

    MDR report key: 2914621 · Received January 14, 2013

    Report

    Report Number
    2520274-2013-00326
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    September 16, 2010
    Manufacturer
    SYNTHES
    Product Code
    JEY
    PMA / PMN Number
    NON-US
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ACTUAL EVENT DATE NOT KNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE (B)(6) REPORTED THAT TWO DRILL BITS WITH THE SAME LOT NUMBER BROKE IN SEPARATE CASES ON THE SAME DAY. THE DRILL GUIDE AND THE CORRECT DRILLING TECHNIQUE WERE UTILIZED. IN ADDITION, THESE DRILL BITS ARE SINGLE USE STERILE ITEMS SO THE SURGEON IS NOT SURE WHY THIS HAPPENED. ONE OF THE DRILL BITS BROKE IN THE PATIENTS BONE AND THEY WERE UNABLE TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21353 DRILL BIT Ø1.5 L125 2FLUTE MIDFACE DRILL BIT JEY SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1