BEUDAMED
    FDA Adverse Event Summary report: N

    CANNULATED TWIST DRILL

    MDR report key: 2484879 · Received March 8, 2012

    Report

    Report Number
    2031009-2012-00003
    Date Received
    March 8, 2012
    Date of Event
    October 22, 2010
    Report Date
    March 7, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION. DEVICE RETURNED TO MFR. DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DRILL.

    Description of Event or Problem · 1

    PRIOR TO SURGERY A SCRUB TECH NOTICED RUST DISCOLORATION ON THE DRILLS IN THE STERILIZATION CADDY. DUE TO CONTAMINATION THE TRAY WAS REMOVED FROM THE OPERATING ROOM. THE SALES REP HAD AN ADDITIONAL SET THAT WAS USED TO COMPLETE THE SURGERY. AFFECTED PARTS WERE REMOVED FROM INVENTORY AND REPLACED WITH DRILLS MARKED BY A A1TIN COATING IN THE LASERMARKED AREA. THE A1TIN COATED DRILLS WERE AVAILABLE FROM A DIFFERENT MFR AND DID NOT SHOW SIGNS OF CORROSION DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED TWIST DRILL 2.4MM CANNULATED TWIST DRILL HRS TRIMED, INC. DRILL-2.4CL

    Patients

    Seq Age Sex Outcome Treatment
    1