BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE GAMMA Ø3,2X450 MM

    MDR report key: 5512950 · Received March 20, 2016

    Report

    Report Number
    0009610622-2016-00142
    Event Type
    Malfunction
    Date Received
    March 20, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 22, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED IN ORIGINALLY SEALED PACKAGING. THERE IS A MISMATCH BETWEEN THE LOT CODE (K04D209) ON THE ORDER LABEL ON THE OUTER PACKAGING (CLEAR TUBE) AND THE LOT CODE (K04C0D2) INDICATED ON THE INNER LABEL (STERILE POUCH) AND PATIENT RECORD LABELS AS WELL AS THE ENGRAVING ON THE K-WIRE ITSELF. THE DHR REVIEW SHOWED THAT THE LOTS K04D209 AND K04C0D2 FOR K-WIRE GAMMA Ø3,2X450 MM, CATALOGUE NUMBER 12106450S HAD BEEN PACKED AND LABELLED BY SUPPLIER STERIPACK ON THE SAME DAY BY DIFFERENT OPERATORS. THE NON-CONFORMANCE MUST HAVE OCCURRED HERE. INCOMING INSPECTION DID NOT DETECT THE NON-CONFORMANCE. THE REPORTED EVENT WAS CAUSED BY A PACKAGING/LABELLING ERROR AT THE SUPPLIER NOT DETECTED BY INSPECTION. (B)(4) WAS OPENED IN ORDER TO ADDRESS FURTHER ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE STRYKER (B)(4) WAREHOUSE, THAT "UPON RECEIPT, IT WAS OBSERVED THAT THE LOT NUMBER OF THE OUTER LABELLING IS DIFFERENT THAN THE PATIENT LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168847 K-WIRE GAMMA Ø3,2X450 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K04D209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other