BEUDAMED
    FDA Adverse Event Other Summary report: N

    4.5 MM TWIST DRILL

    MDR report key: 111706 · Received July 25, 1997

    Report

    Report Number
    2026088-1997-00001
    Event Type
    Other
    Date Received
    July 25, 1997
    Date of Event
    July 10, 1997
    Report Date
    July 24, 1997
    Manufacturer
    AUSTRALIA PTY LTD KNEE DEVELOPMENTS
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, WHILE THE SUBJECT TWIST DRILL WAS STILL WITHIN THE SURGICAL SITE, THE PT'S KNEE SLIPPED OUT OF THE DOCTOR'S GRASP AND EXTENDED TO A POINT WHICH CAUSED THE DRILL BIT TO BE EXPOSED TO EXCESSIVE LEVERAGE, ULTIMATELY CAUSING THE DRILL BIT TO SNAP INTO TWO PIECES. THE DOCTOR ELECTED TO LEAVE THE 2 INCH BROKEN FRAGMENT WITHIN THE SURGICAL SITE, EMBEDDED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE INFO REPORTED HEREIN IS SUPPLIED SOLELY FOR THE USE OF THE FOOD AND DRUG ADMINISTRATION IN ITS FUNCTION UNDER 21 CFR, MEDICAL DEVICE REPORTING, BY SMITH & NEPHEW, INC., DONJOY DIVISION, AS A MFR OR IMPORTER REQUIRED TO REPORT UNDER 21 CFR. SUBMITTED SMITH & NEPHEW, INC., DONJOY DIVISION, REPORTS ARE PROMPTED BY INFO WHICH IS UNVERIFIED AS TO ACCURACY, COMPLETENESS, OR CASUAL RELATION WITH THE PRODUCTS IDENTIFIED. NEITHER THE SUBMISSION OF THE REPORT NOR THE SUPPLY OF ANY INFO HEREIN CONSTITUTES AN ADMISSION OF THE EXISTENCE OF CASUAL CONNECTION BETWEEN A PRODUCT AND DEATH OR SERIOUS INJURY. FURTHER, AS TO THE INCLUSION OF ANY COMPANY CONFIDENTIAL INFO REQUIRED TO BE SUPPLIED IN COMPLIANCE WITH THE AFOREMENTIONED REGULATIONS, SMITH & NEPHEW, INC., DONJOY DIVISION, ASSERTS AND DOES NOT WAIVE ALL RIGHTS TO CONFIDENCE AND PRIVILEGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5 MM TWIST DRILL SURGICAL DRILL HTW AUSTRALIA PTY LTD KNEE DEVELOPMENTS 11-0714-9-00000 M015

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other