BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG MEDIUM BLADE

    MDR report key: 5832802 · Received July 29, 2016

    Report

    Report Number
    5832802
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    June 7, 2016
    Report Date
    July 19, 2016
    Manufacturer
    STRYKER CORP.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LONG MEDIUM STRYKER SAW BLADE WAS USED FOR A KNEE SURGERY. THE SAW BLADE BROKE AT THE BASE OF THE BLADE. A SECOND SAW BLADE WAS GIVEN. THIS SAW BLADE BROKE AS WELL. A NEW SAW WAS OPENED AND A THIRD BLADE WAS GIVEN. THE SAW AND BLADE WERE USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486697 LONG MEDIUM BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER CORP. 320100115302017K

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR NO