BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SYNTHES 2.5MM DRILL BIT

    MDR report key: 8142162 · Received December 6, 2018

    Report

    Report Number
    MW5081931
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 5, 2018
    Manufacturer
    DEPUY SYNTHES INC.
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN THE OPERATING ROOM FOR AN APPLICATION OF UNIPLANAR EXTERNAL FIXATOR SPANNING THE LEFT KNEE AND ORIF OF RIGHT BICONDYLAR TIBIAL PLATEAU FRACTURE WITH PROXIMAL TIBIAL, LATERAL, AND MEDIAL PLATES AND SCREWS. THE TIP OF A DEPUY SYNTHES DRILL BIT, 2.5MM, BROKE OFF IN THE PT'S RIGHT TIBIA. SURGEON ELECTED TO LEAVE THE PIECE IN THE TIBIA SINCE IT WOULD DO MORE HARM TO THE PT TO RETRIEVE IT. DEPUY SYNTHES SALES REP AWARE. PER THE SURGEON, EVENT DISCLOSED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979498 DEPUY SYNTHES 2.5MM DRILL BIT DRILL BIT HTW DEPUY SYNTHES INC. H698169

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other