BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.5 W/STOP L44.5/8 2FLUTE

    MDR report key: 3552059 · Received January 6, 2014

    Report

    Report Number
    2520274-2013-08028
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 17, 2013
    Report Date
    December 18, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE HSZ. DEVICE IS AN INSTRUMENT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE REVIEW OF DEVICE HISTORY RECORDS WAS NOT PERFORMED; THE LOT NUMBER WAS NOT PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6); THAT DURING THE SURGERY ON (B)(6) 2013 THE DRILL BIT BROKE WHEN IT WAS DOING THE FIRST SCREW HOLE; A PORTION OF THE DRILL BIT WAS INSIDE BONE OF PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6606 DRILL BIT Ø1.5 W/STOP L44.5/8 2FLUTE HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR