BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ACUTRAK

    MDR report key: 82582 · Received April 7, 1997

    Report

    Report Number
    3025141-1997-00002
    Event Type
    Injury
    Date Received
    April 7, 1997
    Date of Event
    March 5, 1997
    Report Date
    March 28, 1997
    Manufacturer
    ACUMED, INC.
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE HAND DRILLING WIHT CO'S DRILL, THE SURGEON ENCOUNTERED DENSE BONE AND THE DRILL TIP BROKE AND BECAME LODGED INTO THE BONE. THE TIP WAS LEFT IN THE PT. CO IS AWARE THAT SURGEONS ENCOUNTER DENSE BONE ON OCCASION. CO'S DRILL TIPS SHOULD BE INSPECTED BY THE HOSP BEFORE THEY ARE USED FOR SHARPNESS. THIS RECOMMENDATION IS PUBLIZED IN CO'S SURGICAL TECHNIQUES. CO DOES NOT KNOW IF THIS INSPECTION WAS PERFORMED PRIOR TO SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other