BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER COMMAND II

    MDR report key: 185643 · Received September 1, 1998

    Report

    Report Number
    MW4002324
    Event Type
    Other
    Date Received
    September 1, 1998
    Date of Event
    August 11, 1998
    Report Date
    August 17, 1998
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRILL BIT USED BY SURGEON FOR LACERATED TENDON REPAIR BROKE OFF WHILE IN USE, CAUSING TIP OF BIT TO BE RETAINED IN PT'S LEFT THUMB BONE. DRILL FUNCTION CHECKED OUT PRIOR TO USE AND FOUND TO BE ACCEPTABLE. STRYKER REP STATED THAT IT WAS NOT A FUNCTION OF WHICH HAND PIECE WAS USED. IT IS A FINE DRILL BIT AND THE DRILL BIT BREAKING OFF INTO BONE IS A RECOGNIZED COMPLICATION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER COMMAND II DRILL BIT EJL STRYKER INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other