BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 1812852 · Received July 19, 2010

    Report

    Report Number
    2520274-2010-00143
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Report Date
    July 13, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE MANUFACTURER AND/OR THE DATE OF MANUFACTURE WITHOUT THE RETURNED DEVICE OR THE LOT NUMBER PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    DURING A MAUDE DATABASE SEARCH (B)(6) WAS FOUND: WHILE DOING A FIXATION IN THE RIGHT PROXIMAL METATARSAL, THE 2.5 MM DRILL BIT FROM THE SMALL FRAG SET BROKE. THE BROKEN PIECE SHOWED UP ON A PATIENT X-RAY. SURGEON STATED, "THE DRILL BIT STRENGTHENED THE FIXATION." THE BROKEN DRILL BIT WAS NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.5MM DRILL BIT/QC/GOLD/110MM QUICK COUPLING DRILL BITS HWE SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI