BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

    MDR report key: 5262364 · Received December 2, 2015

    Report

    Report Number
    0009610622-2015-00569
    Event Type
    Malfunction
    Date Received
    December 2, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 10, 2015
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INQUIRY STATES BOTH GUIDE WIRES TO BE THE SUBJECT PRODUCTS. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. THE ITEMS WERE NOT RETURNED TO STRYKER KIEL. A REVIEW OF THE DHRS REVEALED NO DISCREPANCIES, IN PARTICULAR IN THE LABELLING PROCESS. THE DEVICES REPORTED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. ALL LABELS OF THE REPORTED GUIDE WIRE (LOT CODE K130861) INDICATE END OF SHELF LIFE BY (END OF) (B)(6) 2015 RESP. (END OF) (B)(6) 2015 FOR THE REPORTED GUIDE WIRE (LOT CODE K144578). IN THE CASE PRESENTED APPARENT EXPIRED GUIDE WIRES WERE USED IN SURGERY WHICH IS BEYOND THE MANUFACTURER¿S CONTROL. THE STERILITY EXPIRATION DATE OF LOT CODE K130861 WAS EXCEEDED BY APPROX. 41 DAYS (EXPIRY DATE ON LABEL: (B)(6) 2015) RESP. 10 DAYS FOR THE LOT CODE K144578 (EXPIRY DATE ON LABEL: (B)(6) 2015); DATE EVENT OCCURRED: (B)(6) 2015). THUS, THE EVENT DOES NOT PRESENT A MANUFACTURING AND/OR LABELLING ISSUE. REAL AGING TESTS PERFORMED WITH STRYKER IMPLANTS IN 2007 REVEAL THAT THERE IS A SAFETY TOLERANCE; IMPLANTS WITH EXCEEDED EXPIRY DATE WERE CHECKED MORE THAN 1 YEAR OVERDUE AND CONSIDERED STILL STERILE SUBSEQUENTLY. A MEDICAL CONSULTATION IN A SIMILAR CASE (A NAIL HAS BEEN IMPLANTED APPROX. 6 MONTHS AFTER EXPIRY DATE) REVEALED THAT ANY SUCH SITUATION DOES NOT REQUIRE MEDICAL INTERVENTION AND A RISK FOR THE PATIENT IS NOT TO BE EXPECTED. THE EXPIRY DATE IS A THEORETICAL DATE WHICH OFFERS A HIGH LEVEL OF SAFETY AND THE RISK OF AN INFECTION CAUSED BY A SIMPLE TRANSGRESSION OF THE EXPIRY DATE IS NEGLIGIBLE. NEVERTHELESS, THE EXPIRY DATE OF THE USED DEVICES SHOULD HAVE BEEN NOTICED PRIOR TO SURGERY. ACCORDING TO AVAILABLE LABELS IN THE DHRS THE EXPIRY DATE WAS CLEARLY LEGIBLE. FURTHERMORE, THE DEVICES WERE HOSPITAL-OWNED AT THE TIME OF USAGE AND IT SHOULD BE COVERED BY THE HOSPITALS RISK MANAGEMENT. BASED ON THE ABOVE THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICES BUT IS RATHER RELATED TO OFF-LABEL USE. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SURGERY, IT WAS REALIZED THAT THE SURGEON IMPLANTED 2 GUIDE WIRES THAT WERE EXPIRED. THE BALL TIP WIRE EXPIRED IN (B)(6) 2015 AND THE SMOOTH TIP WIRE EXPIRED IN (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793085 GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K144578

    Patients

    Seq Age Sex Outcome Treatment
    1 Other