BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø1 W/STOP L44.5/6 2FLUTE

    MDR report key: 2879377 · Received December 19, 2012

    Report

    Report Number
    2520274-2012-04155
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    April 2, 2010
    Manufacturer
    SYNTHES
    Product Code
    HTW
    PMA / PMN Number
    K974554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 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 EU COMPLAINT HANDLING UNIT REPORTED THAT THE DRILL BIT BROKE DURING SURGERY WHILE DRILLING AND THE BROKEN PART REMAINS IN THE PATIENTS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT Ø1 W/STOP L44.5/6 2FLUTE MIDFACE DRILL BIT HTW SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention