BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARUS

    MDR report key: 87243 · Received April 18, 1997

    Report

    Report Number
    3025141-1997-00003
    Event Type
    Injury
    Date Received
    April 18, 1997
    Date of Event
    March 4, 1997
    Report Date
    April 18, 1997
    Manufacturer
    ACUMED, INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PROXIMAL HUMERUS SURGERY USING CO'S POLARUS SYSTEM WAS PERFORMED. DURING THE SURGERY, THE DRILL BROKE OFF AND THE SURGEON ELECTED TO LEAVE THE DRILL FRAGMENT IN SINCE THE DRILL IS MFR FROM IMPLANT GRADE STAINLESS STEEL. IT WAS DETERMINED THAT THIS FAILURE WAS CAUSED BY USER ERROR AS THE GUIDE WIRE WAS LEFT IN DURING DRILLING; THUS, THE DRILL COLLIDED WITH THE GUIDE WIRE. CO CAUTIONS SURGEONS ABOUT THIS IN THEIR OR SURGICAL TECHNIQUE AND CO'S SALES REPS IN CO'S 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