BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.1 W/STOP L44.5/6 2FLUTE

    MDR report key: 2963080 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-00972
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    July 6, 2009
    Report Date
    July 24, 2009
    Manufacturer
    SYNTHES
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HTW. 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 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

    EU COMPLAINT HANDLING UNIT REPORTED THE TIP OF THE DRILL BIT BROKE OFF IN THE MANDIBLE OF PATIENT. THE TIP STILL REMAINS IN PATIENT. A SECOND TIP BROKE OFF WHEN DRILLING INTO THE ORBITAL RIM. X-RAYS WERE CARRIED OUT ON THE PATIENT AND A SUCTION BAG WAS USED TO TRY AND LOCATE THE MISSING FRAGMENT, HOWEVER THE TIP WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67813 DRILL BIT Ø1.1 W/STOP L44.5/6 2FLUTE DRILL BIT Ø1.1 W/STOP L44.5/6 2FLUTE HSZ SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1