BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICRO 100 SAGITTAL SAW

    MDR report key: 824691 · Received February 23, 2007

    Report

    Report Number
    1017294-2007-00162
    Event Type
    Other
    Date Received
    February 23, 2007
    Date of Event
    January 25, 2007
    Report Date
    January 25, 2007
    Manufacturer
    CONMED LINVATEC
    Product Code
    GET
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM RECEIVED FROM THE USER FACILITY. ALL SECTIONS ON THIS FORM COMPLETED BY THE MFR. INVESTIGATION RESULTS: TO DATE, THIS SAW HAS NOT BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE AN INVESTIGATION HAS BEEN DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THIS SAGITTAL SAW IN A RIGHT KNEE ACL RECONSTRUCTION, THE SAW LEAKED A BLACK RESIDUE RESEMBLING OIL INTO THE SURGICAL SITE. THE SURGICAL SITE WAS FLUSHED WITH SALINE AND SWABBED. ADDITIONALLY, ANTIBIOTIC THERAPY WAS GIVEN FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO 100 SAGITTAL SAW SAGITTAL SAW GET CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other UNIVERSAL HOSE, CAT#00505201000, LOT# UNK