BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYLER TWIST DRILL, 2 X 70 MM

    MDR report key: 99018 · Received June 16, 1997

    Report

    Report Number
    8010177-1997-00011
    Event Type
    Malfunction
    Date Received
    June 16, 1997
    Date of Event
    April 25, 1997
    Report Date
    June 11, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY EVALUATION: EVALUATION RESULTS AS REC'D 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 WERE PLACED IN THE STRYKER DRILL BY THE SCRUB TECHNICIAN. THE FIRST BIT BROKE OFF CLEAN, FLEW ACROSS THE ROOM AND HIT A SURGEON IN THE HAND. THE SECOND DRILL BIT BENT UPON ENGAGING THE DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYLER TWIST DRILL, 2 X 70 MM INSTRUMENT HTW HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other