BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL/2X70MM, STRYKER

    MDR report key: 114404 · Received August 19, 1997

    Report

    Report Number
    8010177-1997-00041
    Event Type
    Malfunction
    Date Received
    August 19, 1997
    Date of Event
    July 7, 1997
    Report Date
    August 18, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: EVALUATION RESULTS AS RECEIVED FROM HOWMEDICA LEIBINGER GMBH INDICATES THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER WOULD BE RELATED TO USER TECHNIQUE.

    Description of Event or Problem · 1

    TWO DRILL BITS BROKE WHILE BEING TESTED IN A STRYKER COMMAND 2 DRILL WHICH WAS SET AT 100%. THE DRILL BITS HAD NO CONTACT WITH THE PATIENT. THE SURGEON SWITCHED DRILLS AND THE PROCEDURE PROCEEDED SMOOTHLY WITHOUT FURTHER INCIDENT. THIS EVENT DID NOT CAUSE ANY ADVERSE CONSEQUENCE TO THE PATIENT OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIST DRILL/2X70MM, STRYKER INSTRUMENT HTW HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other STRYKER COMMAND 2 DRILL