BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LORENZ

    MDR report key: 2992949 · Received August 29, 2012

    Report

    Report Number
    2992949
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    July 12, 2012
    Report Date
    August 29, 2012
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    HTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THIS IS A (B)(6)-YEAR-OLD GENTLEMAN WHO HAD FINISHED UNDERGOING A CORONARY ARTERY BYPASS OPERATION A COUPLE OF HOURS EARLIER. HE BEGAN TO HAVE SIGNIFICANT BLEEDING FROM HIS MEDIASTINAL CHEST TUBES AND AFTER FACTORS WERE GIVEN, THE BLEEDING SLOWED DOWN, BUT HE BEGAN TO EXHIBIT EVIDENCE OF EARLY CARDIAC TAMPONADE. HE WAS THEREFORE BROUGHT BACK TO THE OPERATING ROOM FOR WASHOUT AND ACQUISITION OF HEMOSTASIS. CUTTING OF THE STERNAL WIRES FROM EARLIER CABG X 4 (EMERGENT RETURN TO OR FOR POST-OP BLEEDING). WIRE CUTTER TIP BROKE, X-RAY IN OR DID NOT REVEAL ANY RESIDUAL INSTRUMENTATION/PIECES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CUTTING OF THE STERNAL WIRES FROM EARLIER CABG X 4 (EMERGENT RETURN TO OR FOR POST-OP BLEEDING). WIRE CUTTER TIP BROKE, X-RAY IN OR DID NOT REVEAL ANY RESIDUAL INSTRUMENTATION/PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LORENZ WIRE CUTTER HTZ BIOMET MICROFIXATION, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR DURING AN EMERGENT RETURN TO OR FOR CONTROL OF CHE| GEON USING STERNAL WIRE CUTTERS AND TIP OF INSTRUM| ENT BROKE OFF.| ST BLEEDING POST-CAB (CORONARY ARTERY BYPASS), SUR