BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X30 MM

    MDR report key: 4091185 · Received September 16, 2014

    Report

    Report Number
    0009610726-2014-00001
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED LOCKING SCREW WAS NOT RETURNED TO STRYKER KIEL AS THE PRODUCT IS NOT AVAILABLE FOR EVALUATION DUE TO ¿HOSPITAL POLICY¿. REVIEW OF THE DHR OF THE LOCKING SCREW REPORTED DID NOT INDICATE ANY DEVIATIONS; THE DHR CONTAIN A COPY OF THE LABEL SET (LABEL FOR PACKAGING AND PATIENT RECORD LABEL). ALL LABELS INDICATE END OF SHELF LIFE BY (END OF) DECEMBER 2013 (NOMINAL VALUE). THE DEVICE REPORTED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. 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 REPORTED LOCKING SCREW SHOULD HAVE BEEN NOTICED PRIOR TO SURGERY. BASED ON THE ABOVE THE EVENT IS NOT LINKED TO A DEFICIENCY OF THE DEVICE BUT IS RATHER RELATED TO OFF-LABEL USE. NO NON-CONFORMITY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY MID-SHAFT TIBIAL SURGERY, A LOCKING SCREW WAS IMPLANTED WHICH WAS EXPIRED ON 12/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY MID-SHAFT TIBIAL SURGERY, A LOCKING SCREW WAS IMPLANTED WHICH WAS EXPIRED ON 12/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573256 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X30 MM IMPLANT HSB STRYKER TRAUMA KIEL K107663

    Patients

    Seq Age Sex Outcome Treatment
    1 Other