BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP T2 TIBIA +10 MM

    MDR report key: 8660745 · Received May 31, 2019

    Report

    Report Number
    0009610622-2019-00467
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 26, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540197566
    PMA / PMN Number
    K003018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE FAILURE WAS CAUSED BY A MIX UP AT THE CUSTOMER'S FACILITY. MOST PROBABLY THE UPPER PART OF THE PACKAGING FOR THE CAT#18220015S AND LOT#K0EC9E7 AND THE LOWER PART FOR THE CAT#18220010S AND LOT#K06E4D5 WERE MIXED. THE INVESTIGATION REVEALED THAT THE PACKAGING WAS PERFORMED AT SUPPLIER. THERE ARE NO ERRORS DOCUMENTED IN THE WORK ROUTERS AT SUPPLIER NOR AT STRYKER TRAUMA GMBH. NO ADDITIONAL LABEL PRINTS WERE PERFORMED. THE PARTS WERE PACKED AND RELEASED WITH APPROX. A HALF YEAR IN BETWEEN. 06E4D5 Ø10 IN JULY 2018 AND 0EC9E7 Ø15 IN DEC 2018. THIS MEANS THAT THE LABELS FOR 0EC9E7 COULD NOT HAVE BEEN PRINTED WHEN 06E4D5 WAS PACKED. THE WORK ROUTER FOR 0EC9E7 WAS NOT CREATED AT THAT TIME. ADDITIONALLY, THE OVERWRAP DOES NOT LOOK LIKE THE OVERWRAP USED BY THE PACKAGING SUPPLIER. ON THE PICTURES OF THE ARTICLE IN QUESTION THERE IS NO PERFORATION LINE VISIBLE THAT IS USED FOR THE OVERWRAP. THEREFORE, THE MIX OF LABELS OF THE TWO DIFFERENT LOTS COULD NOT HAVE HAPPENED AT THE SUPPLIER OR STRYKER. THIS CASE IS THEN CLASSIFIED AS A USER RELATED ISSUE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    OUR SALES REP. COMPLAINED THAT IN THE KIT THERE WAS 2 END CUP +15 MM. BUT ACTUALLY OUR KIT ROOM CHECKED (ONCE THE KIT HAS BEEN RETURNED) THAT THE LABELS ON ONE END CUP'S BOX ARE DIFFERENT: ONE OF THEM (THE ONE WITH THE BAR CODE) SHOWS 18220010S LOT K06E4D5, AND THE ONE SMALLER ON THE SIDE OF THE BOX SHOWS 18220015S LOT K0EC9E7. THE PACKAGE IS UNOPENED.

    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

    OUR SALES REP. COMPLAINED THAT IN THE KIT THERE WAS 2 END CUP +15 MM. BUT ACTUALLY OUR KIT ROOM CHECKED (ONCE THE KIT HAS BEEN RETURNED) THAT THE LABELS ON ONE END CUP'S BOX ARE DIFFERENT: ONE OF THEM (THE ONE WITH THE BAR CODE) SHOWS 18220010S LOT K06E4D5, AND THE ONE SMALLER ON THE SIDE OF THE BOX SHOWS 18220015S LOT K0EC9E7. THE PACKAGE IS UNOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453922 END CAP T2 TIBIA +10 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K06E4D5 04546540197566

    Patients

    Seq Age Sex Outcome Treatment
    1