BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 3132825 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02824
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE LEFT DISTAL HUMERUS ON (B)(6) 2013. AS THE SURGEON WAS DRILLING WITH A 2.5MM DRILL BIT TO PREPARE TO INSERT 3.4MM CORTICAL SCREWS, THE TIP OF THE DRILL BIT BROKE OFF IN THE PATIENTS BONE AND REMAINS IMPLANTED. THE REST OF THE BROKEN DRILL BIT WAS RETRIEVED AND DISCARDED BY THE HOSPITAL. THE SURGEON USED ANOTHER DRILL BIT AND COMPLETED THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235972 2.5MM DRILL BIT/QC/GOLD/110MM HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR