BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *ALZ/TWIST DRILL/1.5X125MM

    MDR report key: 172005 · Received June 8, 1998

    Report

    Report Number
    8010177-1998-00049
    Event Type
    Malfunction
    Date Received
    June 8, 1998
    Report Date
    June 5, 1998
    Manufacturer
    HOWMEDICA INC
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO: THERE WERE TWO DRILLS INVOLVED IN THE EVENT. SUMMARY OF EVALUATION: THE DRILLS WERE EXAMINED AND BOTH WERE DETERMINED TO HAVE FAILED DUE TO TORSIONAL/BENDING OVERLOAD.

    Description of Event or Problem · 1

    ACCORDING TO THE SURGEON, THE TWIST DRILL SNAPPED OFF INSIDE THE DRILL GUIDE WHILE DRILLING INTO THE PT'S MANDIBLE. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PORTION OF THE DRILL. THE PT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 *ALZ/TWIST DRILL/1.5X125MM INSTRUMENT HTW HOWMEDICA INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other