BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLIS OSTEOTOME

    MDR report key: 2068490 · Received April 20, 2011

    Report

    Report Number
    2068490
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    February 3, 2011
    Report Date
    April 20, 2011
    Manufacturer
    LIFE INSTRUMENTS CORP.
    Product Code
    HWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE OSTEOTOME THE INSTRUMENT BROKE. THE TIP OF THE INSTRUMENT WAS LODGED IN THE PATIENT'S HIP. THE OSTEOTOME WAS ABLE TO BE REMOVED DURING THE CASE AND X-RAYS WERE TAKEN USING THE C-ARM. THIS INCIDENT EXTENDED THE LENGTH OF THE CASE APPROXIMATELY 1 1/2 HOURS.THE SAME BRAND OF OSTEOTOME HAD BROKEN A FEW WEEKS PRIOR TO THIS ONE BREAKING.THE ONLY CONSEQUENCE I KNOW OF WAS THAT THE CASE WAS EXTENDED BY AT LEAST 1 HOUR DO TO THE INSTRUMENT BREAKING WHICH PROLONGED THE ANESTHESIA TIME OF THE PATIENT.AFTER THE OSTEOTOME WAS REMOVED I AM NOT SURE WHAT DOCTOR USED TO COMPLETE THE CASE.THE BROKEN TIP OF THE OSTEOTOME WAS LODGED IN THE PATIENT'S HIP. THAT PIECE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLIS OSTEOTOME OSTEOTOME HWM LIFE INSTRUMENTS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR