BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMED TWIST DRILL

    MDR report key: 2524921 · Received March 30, 2012

    Report

    Report Number
    2031009-2012-00009
    Date Received
    March 30, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 29, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION. DEVICE NOT RETURNED TO MANUFACTURE. DEVICE IS NOT IMPLANTABLE GRADE MATERIAL AND WAS NOT REMOVED FROM PT. FUTURE PT INTERVENTION MAY BE NECESSARY BASED UPON REACTION TO MATERIAL.

    Description of Event or Problem · 1

    PT UNDERWENT OPEN REDUCTION INTERNAL FIXATION OF LEFT COMMINUTED INTRA-ARTICULAR RADIUS FRACTURE. DURING PROCEDURE, PIECE OF DRILL BIT BROKE OFF. SURGEON DETERMINED TO LEAVE PIECE EMBEDDED IN THE BONE. SALES REP FOR TRIMED REPORTED THAT THE PT HAD FAIRLY HARD BONE QUALITY. THE DRILL BROKE AFTER BEING USED ON AT LEAST 3 HOLES PRIOR. DRILLING WAS DONE WITH PROPER IRRIGATION AND DID NOT IMPINGE ON OTHER HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMED TWIST DRILL 1.75MM TWIST DRILL HRS TRIMED, INC. DRILL-1.75 96381

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR