BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES 2.5MM DRILL BIT

    MDR report key: 3931165 · Received July 14, 2014

    Report

    Report Number
    3931165
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES, INC.
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING EXTENSIVE ORTHOPEDIC SURGERY, INCLUDING REPAIR OF AN OPEN HUMERAL FRACTURE. DURING REPAIR OF THE HUMERAL FRACTURE, THE TIP OF THE DRILL BIT BROKE OFF AND BECAME LODGED IN THE BONE. THE SURGEON WAS MADE AWARE AND A DECISION MADE TO LEAVE IT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411322 SYNTHES 2.5MM DRILL BIT SYNTHES 2.5MM DRILL BIT HWE SYNTHES, INC. U194328

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other