BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE GAMMA3® 300X160MM

    MDR report key: 3946100 · Received July 21, 2014

    Report

    Report Number
    0009610622-2014-00348
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 30, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K123401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT INQUIRY STATES THE TARGET DEVICE GAMMA3 TO BE THE SUBJECT PRODUCT. THE REPORTED TARGETING SLEEVE AND KNOB ARE REGARDED AS ASSOCIATED PRODUCTS. A PHYSICAL EXAMINATION COULD NOT BE CARRIED OUT AS THE DEVICES WERE NOT RETURNED TO STRYKER KIEL. A REVIEW OF THE DEVICE HISTORY COULD NOT BE CARRIED OUT AS THE LOT CODES OF THE REPORTED INSTRUMENTS ARE UNKNOWN. THUS, A REASONABLE EXAMINATION AND INVESTIGATION WAS NOT POSSIBLE. THE REPORTED EVENT (¿DISTAL MIS-TARGETING DURING A SURGERY PROCEDURE ¿) COULD NOT BE CONFIRMED. WITH THE INFORMATION GIVEN THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. POTENTIALLY REDUCED ACCURACY IN GUIDANCE IS USUALLY FOUND DURING FUNCTIONAL CHECK (REQUIRED PER IFU). IN CASE OF ANY DEVIATION IT IS REALIZED PRIOR TO USE. NO NON-CONFORMITY WAS IDENTIFIED. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE HOSPITAL THAT THERE WAS A DISTAL MIS-TARGETING DURING A SURGERY PROCEDURE. THE SURGERY WAS COMPLETED BY USING FREEHAND TARGETING.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE HOSPITAL THAT THERE WAS A DISTAL MIS-TARGETING DURING A SURGERY PROCEDURE. THE SURGERY WAS COMPLETED BY USING FREEHAND TARGETING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424665 TARGET DEVICE GAMMA3® 300X160MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other