BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø4.5/2.1 CANN CALIBR L230/210

    MDR report key: 2930119 · Received January 25, 2013

    Report

    Report Number
    2520274-2013-00641
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 21, 2009
    Report Date
    December 21, 2009
    Manufacturer
    SYNTHES
    Product Code
    JDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. (B)(4). 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. 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

    (B)(6) REPORTED A GUIDE WIRE BECAME HOT AND BROKE. WHILE DRILLING, THE GUIDE WIRE BECAME OVERHEATED AND THE TIP BROKE OFF. ONLY THE DRILL BIT IS AVAILABLE FOR INVESTIGATION. THE GUIDE WIRE IS NOT AVAILABLE. THE BROKEN PART OF THE GUIDE WIRE REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35043 DRILL BIT Ø4.5/2.1 CANN CALIBR L230/210 DRILL BIT Ø4.5/2.1 CANN CALIBR JDW SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1