BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARUS

    MDR report key: 78444 · Received March 21, 1997

    Report

    Report Number
    3025141-1997-00001
    Event Type
    Injury
    Date Received
    March 21, 1997
    Date of Event
    February 18, 1997
    Report Date
    March 14, 1997
    Manufacturer
    ACUMED, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PROXIMAL HUMERUS SURGERY USING CO'S DEVICE WAS PERFORMED. DURING SURGERY, DRILL BROK OFF AND SURGEON ELECTED TO LEAVE THE DRILL FRAGMENT IN SINCE THE DRILL IS MANUFACTURED FROM IMAPLNT GRADE STAINLESS STEEL. IT WAS DEETRMINED THAT THIS FAILURE WAS CAUSED BY USER ERROR AS THE GUIDE WIRE WAS LEFT IN DURING DRILLING; THUS, DRILL COLLIDED WITH GUIDE WIRE. CO CAUTIONS SURGEONS ABOUT THIS IN SURGICAL TECHNIQUE AND SALES REPS IN TRAINING SESSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARUS DRILL HTW ACUMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other