BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    MDR report key: 3903977 · Received July 1, 2014

    Report

    Report Number
    0009610622-2014-00303
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 6, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO DEVIATION FOUND IN MANUFACTURING. NO DISCREPANCIES FOUND REGARDING RISK ANALYSIS. REVIEW OF THE MANUFACTURING FOR LOT K212439 CONFIRMED THAT THE CARDBOARD BOXES WERE SEALED WITH A SHRINK WRAP PRIOR TO INITIAL DISTRIBUTION. THE PACKAGING WAS CORRESPONDING TO ITS SPECIFICATIONS AT TIME OF INITIAL DISTRIBUTION. INVESTIGATION REVEALED THAT AN ALREADY OPENED SECONDARY PACKAGING (CARDBOARD BOX) CONTAINING AN ALREADY OPENED PRIMARY PACKAGING (BLISTER) HAD BEEN OVERWRAPPED AGAIN AT THE DISTRIBUTION SITE AND THEN WAS DISTRIBUTED TO THE END USER. THE MANUFACTURER STRYKER KIEL HAS VALIDATED PACKAGING PROCESSES AND THE PACKAGING DESIGN AS WELL. IN THIS CASE THE PACKAGING DESIGN WAS MODIFIED UNAUTHORIZED AT THE DISTRIBUTION SITE (REMOVAL OF THE ORIGINAL OVERWRAP AND REPLACEMENT BY OTHER NOT VALIDATED OVERWRAP). THE NONCONFORMANCE (OPEN PRIMARY PACKAGING INSIDE BOX) WAS CAUSED BY UNAUTHORIZED AND NOT VALIDATED RE-PACKAGING AT THE DISTRIBUTION SITE. THE MANUFACTURER REJECTS THE RESPONSIBILITY FOR NOT AUTHORIZED RE-PACKAGING PRACTICES AT THE DISTRIBUTION SITE.

    Description of Event or Problem · 1

    THERE WERE 2 UNITS FROM THIS SAME LOT IN THE STORAGE AREA BELONGING TO THE SALES REP. THE PRIMARY PACKAGE WERE OPENED. THE OTHER ONE HAS THE SECONDARY PACKAGE STILL CLOSED AND THEY WILL RETURN IT FOR ANALYSIS.

    Description of Event or Problem · 1

    THERE WERE 2 UNITS FROM THIS SAME LOT IN THE STORAGE AREA BELONGING TO THE SALES REP. THE PRIMARY PACKAGE WERE OPENED. THE OTHER ONE HAS THE SECONDARY PACKAGE STILL CLOSED AND THEY WILL RETURN IT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383059 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K212439

    Patients

    Seq Age Sex Outcome Treatment
    1 Other