BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING SLEEVE GAMMA3 200

    MDR report key: 4220590 · Received November 3, 2014

    Report

    Report Number
    0009610622-2014-00614
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT INQUIRY STATES BOTH, THE TARGETING SLEEVE GAMMA3 200 AND THE KNOB F. TARGET DEVICE GAMMA3 Ø40X50MM TO BE SUBJECT PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. 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 IS UNKNOWN. THUS, A REASONABLE EXAMINATION AND INVESTIGATION WAS NOT POSSIBLE. THE REPORTED EVENT (¿MISDRILLINGS OCCURRED¿) COULD NOT BE CONFIRMED. WITH THE INFORMATION AVAILABLE THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE FILE WILL BE CLOSED FORMALLY IN ACCORDANCE TO OUR PROCEDURES. IN CASE THE ITEMS AND / OR SUBSTANTIVE INFORMATION WILL BECOME AVAILABLE IN FUTURE THE FILE WILL BE REVIEWED AND REOPENED. FURTHER, AS BOTH DEVICES MUST HAVE BEEN IN USE FOR A LONGER TIME WE PRESUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. BOTH DEVICES ARE PHASED OUT ALREADY AND ARE NOT DISTRIBUTED ANY LONGER. THEY HAVE BEEN REPLACED BY A NEW DESIGN VERSION: SPEEDLOCK SLEEVE GAMMA3 200, CAT. # 13201120. THE LAST TARGETING SLEEVE GAMMA3 200 HAD BEEN DISTRIBUTED IN JULY 2009 AND THE LAST KNOB F. TARGET DEVICE GAMMA3 Ø40X50MM IN SEPTEMBER 2009.´NO NON-CONFORMITY WAS IDENTIFIED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON THAT MISDRILLINGS OCCURED. A REPLACEMENT WAS AVAILABLE TO COMPLETE THE SURGERY.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE SURGEON THAT MISDRILLINGS OCCURED. A REPLACEMENT WAS AVAILABLE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702691 TARGETING SLEEVE GAMMA3 200 INSTRUMENT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other