BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT TRAY, BASIC T2 FEMUR LONG

    MDR report key: 3092716 · Received May 3, 2013

    Report

    Report Number
    0009610622-2013-00035
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS NOT CONFIRMED. AN INVESTIGATION OF THE PRODUCTS AND A REVIEW OF THE DHR WERE NOT POSSIBLE, THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED. ALL THESE PRODUCTS AND TRAY ARE CLEANABLE AND STERILIZABLE DESIGNED; SOME INSTRUMENTS MUST BE DISASSEMBLED PRIOR TO CLEANING (I.E. SCREW GAUGES) LIKE RECOMMENDED IN THE REPROCESSING GUIDE. ALL THESE INSTRUMENTS AND TRAY ARE SOLD IN UNSTERILE CONDITION, THIS MEANS ALL INSTRUMENTS AND TRAY MUST BE CLEANED AND STERILIZED PRIOR EVERY SURGERY LIKE RECOMMEND IN THE IFUS. THE MANUFACTURER DOES NOT HAVE ANY INFLUENCE TO THE CLEANNESS OF UNSTERILE PRODUCTS. THE REPORTED ISSUE IS ATTRIBUTED TO A USER ERROR.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUAITON. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    UPON SELECTION OF A SHEATHED HEX SCREWDRIVER, FOR SCREW REMOVAL, THE SCRUB NURSE DISCOVERED THAT THE INSIDE OF THE SCREWDRIVER SHEATH WAS HEAVILY CONTAMINATED. FURTHER INVESTIGATION DISCOVERED SIMILAR LEVELS OF CONTAMINATION THROUGHOUT ALL SHEATHED INSTRUMENTS AND ALL CANNULATED INSTRUMENTS. T2 BASIC INSTRUMENTS SET, ALL CANNULATED/SHEATHED INSTRUMENTS ON TRAY WERE AFFECTED. SMALL 10 MINUTE DELAY IN SURGERY TIME.

    Description of Event or Problem · 1

    UPON SELECTION OF A SHEATHED HEX SCREWDRIVER, FOR SCREW REMOVAL, THE SCRUB NURSE DISCOVERED THAT THE INSIDE OF THE SCREWDRIVER SHEATH WAS HEAVILY CONTAMINATED. FURTHER INVESTIGATION DISCOVERED SIMILAR LEVELS OF CONTAMINATION THROUGHOUT ALL SHEATHED INSTRUMENTS AND ALL CANNULATED INSTRUMENTS. T2 BASIC INSTRUMENTS SET, ALL CANNULATED/SHEATHED INSTRUMENTS ON TRAY WERE AFFECTED. SMALL 10 MINUTE DELAY IN SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194514 INSTRUMENT TRAY, BASIC T2 FEMUR LONG INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other