BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW, TI GAMMA3® Ø8X17.5MM

    MDR report key: 4112544 · Received September 24, 2014

    Report

    Report Number
    0009610622-2014-00493
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    EVALUATION SUMMARY: PRODUCT INQUIRY STATES THE LONG NAIL KIT R1.5, WHICH INCLUDES THE SET SCREW RETURNED, AND THE REPORTED SPARE SET SCREW TO BE THE SUBJECT PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. THE LONG NAIL AND THE SPARE SET SCREW WERE NOT RETURNED AS THEY WERE STILL IMPLANTED. NO DEVIATIONS WERE FOUND DURING THE REVIEW OF THE MANUFACTURING DOCUMENTS OF THE LONG NAIL KIT. THE LONG NAIL AND THE SET SCREW WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE SET SCREW RETURNED SHOWS TRACES OF USE. THE THREAD OF THE DEVICE IS SLIGHTLY DAMAGED AND FLATTENED. NEVERTHELESS A FUNCTIONAL TEST PERFORMED ON A THREADED RING GAUGE AND ON A SAMPLE NAIL REVEALED THE FUNCTION OF THE DEVICE TO BE FULLY GIVEN. THE SET SCREW COULD BE INSERTED INTO THE THREADED RING GAUGE AND INTO THE NAIL TO ITS DESIRED END POSITION WITHOUT ANY DIFFICULTIES. THE REPORTED EVENT (¿DID NOT BE INSERTED TO INNER THREAD OF THE NAIL¿) COULD NOT BE REPRODUCED. BASED ON THE ABOVE FACTS IT CAN BE ASCERTAINED THAT THE ROOT CAUSE IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER LINKED TO AN INADEQUATE HANDLING BY THE USER. A PHYSICAL EXAMINATION OF THE SPARE SET SCREW COULD NOT BE CARRIED OUT AS THE DEVICE WAS NOT RETURNED TO STRYKER (B)(4). A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE AS THE LOT CODE IS UNKNOWN AND COULD NOT BE PROVIDED. THUS, A REASONABLE EXAMINATION AND INVESTIGATION OF THE SPARE SET SCREW WAS NOT POSSIBLE. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE SPARE SET SCREW WAS IMPLANTED, BUT IS NOT FUNCTIONAL AS THE SET SCREW COULD NOT BE INSERTED TO ITS DESIRED END POSITION. THE IMPLANTED LAG SCREW MIGHT THEREFORE NOT BE SECURED PROPERLY. NEVERTHELESS THE REPORTED EVENT (¿A SPARE SET SCREW WAS USED BUT SAME SITUATION WAS CONFIRMED ¿) COULD NOT BE CONFIRMED. FURTHER INFORMATION SUCH AS OP REPORTS AND X-RAYS WERE REQUESTED, BUT HAD NOT BEEN AVAILABLE. WITH THE INFORMATION GIVEN THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. IN ORDER TO EASE THE SET SCREW INSERTION AND TO AVOID SET SCREW DAMAGES THE GAMMA3 CLOSE TUBE CLIP IS AVAILABLE SINCE 2007. THE OPERATIVE TECHNIQUE CLEARLY POINTS OUT THAT THE SET SCREW MUST BE USED. THE USE OF THE SET SCREW IS NOT AN OPTION. IN THIS CASE THE USE OF ANOTHER SET SCREW OR OF ANOTHER LONG NAIL KIT COULD HAVE BEEN POSSIBLE ALLOWING THE CONFORMANCE TO THE REQUIREMENTS OF THE PROCEDURE. NEVERTHELESS IT IS THE FINAL DECISION OF THE SURGEON AND IN HIS RESPONSIBILITY TO LEAVE THE LAG SCREW UNSECURED TOWARDS ROTATION AND UNCONTROLLED SLIDING. NO NON-CONFORMITY WAS IDENTIFIED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING GAMMA3 SURGERY, THE SET SCREW WHICH WAS IN THE NAIL KIT COULD NOT DID NOT BE INSERTED INTO THE INNER THREAD OF THE NAIL. A SPARE SET SCREW WAS USED BUT SAME SITUATION WAS CONFIRMED.

    Description of Event or Problem · 1

    DURING GAMMA3 SURGERY, THE SET SCREW WHICH WAS IN THE NAIL KIT COULD NOT DID NOT BE INSERTED INTO THE INNER THREAD OF THE NAIL. A SPARE SET SCREW WAS USED BUT SAME SITUATION WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593191 SET SCREW, TI GAMMA3® Ø8X17.5MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other