BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 5048615 · Received September 1, 2015

    Report

    Report Number
    0008031020-2015-00372
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 12, 2015
    Manufacturer
    STRYKER GMBH (MDR)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT 5XSTST AND 5X TI WERE BUILT UP THE SAME DAY. AT THE LAST STEP OF PACKAGING IT HAS BEEN MIX-UP. THE SCREW RACK IS ACTUALLY THE SAME FOR BOTH TYPES OF SCREWS AND BOTH ARE INDISTINGUISHABLE FROM EACH OTHER. THE SHIPPING BOX, WHICH (B)(4) COMPILES AS KITTING SERVICE, CONTAINS THE NON-STERILE SCREW RACK AND SOME OTHER INSTRUMENTS OR STERILE SCREWS, DEPENDING ON WHAT WAS ORDERED BY THE DISTRIBUTION SITE. IN THIS CASE, THE RACKS HAVE BEEN MIXED WITH THE OTHER SHIPPING BOX. THE SCREWS, THE COMBINATION OF THE SCREWS IN THE RACK, THE STERILE PACKED SCREWS AND THE WHOLE LABELLING ARE NOT CONCERNED. NO RISK HAS BEEN IDENTIFIED FOR THE PATIENT SINCE THE INSTRUMENTATION IS THE SAME FOR BOTH TYPE OF SCREWS. THE RACKS WILL BE EXCHANGED AS A CORRECTION. NO FURTHER ACTION IS NECESSARY, EVERYTHING WILL BE DOCUMENTED IN THE NC. UNKNOWN ASNIS 4.0 TI SET.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT 5XSTST AND 5X TI WERE BUILT UP THE SAME DAY. AT THE LAST STEP OF PACKAGING IT HAS BEEN MIX UP. THE SCREW RACK IS ACTUALLY THE SAME FOR BOTH TYPES OF SCREWS AND BOTH ARE INDISTINGUISHABLE FROM EACH OTHER. THE SHIPPING BOX, WHICH SELZACH COMPILES AS KITING SERVICE, CONTAINS THE NON STERILE SCREW RACK AND SOME OTHER INSTRUMENTS OR STERILE SCREWS, DEPENDING ON WHAT WAS ORDERED BY THE DISTRIBUTION SITE. IN THIS CASE, THE RACKS HAVE BEEN MIXED WITH THE OTHER SHIPPING BOX. THE SCREWS, THE COMBINATION OF THE SCREWS IN THE RACK, THE STERILE PACKED SCREWS AND THE WHOLE LABELING ARE NOT CONCERNED. NO RISK HAS BEEN IDENTIFIED FOR THE PATIENT SINCE THE INSTRUMENTATION IS THE SAME FOR BOTH TYPE OF SCREWS. THE RACKS WILL BE EXCHANGED AS A CORRECTION. NO FURTHER ACTION IS NECESSARY, EVERYTHING WILL BE DOCUMENTED IN THE NC.

    Description of Event or Problem · 1

    I RECEIVED WHAT WAS SUPPOSED TO BE TWO NEW ASNIS 4.0 TI SETS FROM IOC/STRYKER TODAY AND AFTER OPENING THE SETS FOUND THAT THEY WERE IN FACT ASNIS 4.0 SS SETS. THE INTERESTING PART IS THAT ALL THE STERILE SCREWS WERE INDEED TI, HOWEVER THE OPEN SCREWS IN THE CADDIES, THE WASHERS, AND THE DRILLS WERE SS. BELOW ARE SOME DETAILS FROM EACH SET. PLEASE LET ME KNOW HOW WE SHOULD PROCEED TO REMEDY THIS ISSUE.

    Description of Event or Problem · 1

    I RECEIVED WHAT WAS SUPPOSED TO BE TWO NEW ASNIS 4.0 TI SETS FROM IOC/STRYKER TODAY AND AFTER OPENING THE SETS FOUND THAT THEY WERE IN FACT ASNIS 4.0 SS SETS.. THE INTERESTING PART IS THAT ALL THE STERILE SCREWS WERE INDEED TI, HOWEVER THE OPEN SCREWS IN THE CADDIES, THE WASHERS, AND THE DRILLS WERE SS. BELOW ARE SOME DETAILS FROM EACH SET. PLEASE LET ME KNOW HOW WE SHOULD PROCEED TO REMEDY THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579368 UNKNOWN_SELZACH_PRODUCT NA HRS STRYKER GMBH (MDR) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other