BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP T2 TIBIA +15 MM

    MDR report key: 4854453 · Received June 18, 2015

    Report

    Report Number
    0009610622-2015-00305
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    STRYKER TRAUMA KIEL (MDR)
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY:INVESTIGATION REVEALED THAT THE DEVICE SHOWED AN ENGRAVING "+5" INSTEAD OF THE INTENDED "+15" ON THE SHAFT. ALL OTHER FEATURES OF THE ENGRAVING (CATALOGUE NUMBER 1822-0015 AND LOT CODE K763315) ON THE FRONT SURFACE WERE CORRECT. DURING REVIEW OF THE DHR NO DEFICIENCY IN DIMENSION IT WAS DETERMINED. FURTHER, IT WAS DETERMINED THAT THE ITEM IN QUESTION HAD BEEN ENGRAVED AT A SUB-SUPPLIER ON (B)(6) 2011. THE ENGRAVING PROGRAM WAS RECORDED HAND-WRITTEN BEING ¿18220015 / +5¿ WHICH CORRESPONDS TO CORRECT CAT-NO BUT TO WRONG LENGTH. LOCAL INVESTIGATION OF THE SUB-SUPPLIER CONFIRMED ABOVE DISCREPANCY ON (B)(6) 2015. A REVIEW OF THE MANUFACTURER¿S COMPLAINT-DATABASE AND OF THE CAPA-DATABASE REVEALED NO FURTHER MATTERS REGARDING THIS LOT AND REGARDING OTHER END CAPS. THUS, IT WAS CONCLUDED THAT THE MATTER WAS TIED TO THIS SPECIFIC SINGLE LOT. IT WAS CONCLUDED THAT 100% OF THE ITEMS OF THIS LOT WERE AFFECTED. THE EVENT OF INSUFFICIENT ENGRAVING WAS ANALYZED UNDER NC (B)(4). AS THE AFFECTED LOT HAD BEEN IN THE MARKET FOR APPROX. 4 YEARS AND AS NO COMPLAINT WAS FILED UNTIL DATE (REGARDING WRONG ENGRAVING) IT WAS CONCLUDED THAT THE USER RELIES ON THE APPEARANCE / ACTUAL SIZE AND ON THE ENGRAVING ON THE FRONT SURFACE. THE EVENT WAS CAUSED BY A HUMAN ERROR DURING THE ENGRAVING PROCESS. PRODUCT WAS NOT RETURNED.

    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 NURSE OF THE HOSPITAL, THAT THE END CAP IS WRONGLY ENGRAVED.

    Description of Event or Problem · 1

    IT IS REPORTED BY THE NURSE OF THE HOSPITAL, THAT THE END CAP IS WRONGLY ENGRAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398093 END CAP T2 TIBIA +15 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL (MDR) K763315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other