BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMED

    MDR report key: 377482 · Received February 15, 2002

    Report

    Report Number
    MW1024099
    Event Type
    Injury
    Date Received
    February 15, 2002
    Date of Event
    January 22, 2002
    Report Date
    January 22, 2002
    Manufacturer
    ACUMED, INC.
    Product Code
    HXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACUMED MINI ACUTRAK CANNULATED HEX DRIVER TIP BROKE OFF WHILE INSERTING SCREW INTO BONE. TIP FOUND AND REMOVED WITH USE OF X-RAY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/5/02: THE MINI-ACUTRAK CANNULATED HEX DRIVER HAS UNDERGONE THREE SIGNIFICANT DESIGN MODIFICATIONS. THE FIRST DESIGN CHANGE (6/25/97) INVOLVED THE ADDITION OF A GROOVE NEAR THE TIP OF THE DRIVER. THIS GROOVE PROVIDES A CONTROLLED BREAK-OFF POINT ENABLING THE SURGEON TO EASILY REMOVE THE BROKEN TIP SHOULD THE SURGEON APPLY EXCESSIVE TORQUE TO THE DRIVER. THE SECOND DESIGN CHANGE (5/10/01) INVOLVED A CHANGE IN HEAT TREATING THE PART TO IMPROVE TORQUE RESISTANCE. THE THIRD DESIGN CHANGE (6/12/01) INVOLVED THE INCREASING THE CANNULATION OF THE DRIVER TO ACCOMMODATE A WIDER DIAMETER K-WIRE. TEST DATA ON FILE AT ACUMED CONCLUDES THAT EVEN WITH THE INCREASE IN CANNULATION DIAMETER, THE DRIVERS STILL POSSESS A TORQUE VALUE SIGNIFICANTLY ABOVE (6.19 IN/LBS) WHICH COMPLIES WITH ISO 8319-1. TO ADDRESS THE QUESTION OF LIFE EXPECTANCY AND ANTICIPATED FAILURE RATE, PLEASE REFER TO THE PACKAGE INSERT FOR REUSABLE INSTRUMENTS. WITHIN THE INFO FOR USE SECTION, MFR MAKES THE STATEMENT THAT INSTRUMENTS ARE REUSABLE AND HAVE A LIMITED LIFE SPAN. INSERT FURTHER REQUIRES THE USER TO INSPECT THE INSTRUMENTS FOR SHARPNESS, WEAR, DAMAGE, PROPER CLEANING, CORROSION, AND INTEGRITY OF CONNECTING MECHANISMS PRIOR TO AND AFTER TO EVERY USE. PLEASE NOTE THAT MFR EMPHASIZES THE FOLLOWING: "PARTICULAR ATTENTION SHOULD BE PAID TO HEX DRIVERS, DRILL BITS, AND ANY INSTRUMENTS USED FOR CUTTING OR IMPLANT INSERTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMED MINI ACUTRAK CANNULATED HEX DRIVER HXY ACUMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention