BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM/0 ANGLE FOR PIP ARTHRODESIS

    MDR report key: 2935953 · Received January 30, 2013

    Report

    Report Number
    0008031020-2013-00005
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K070598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    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: THE VISUAL INSPECTION REVEALED THE BOX IS DESTROYED. IT WAS NOT OPENED IN A GOOD WAY. THE LABELING IS DAMAGED WHICH INDICATE PRODUCT WAS STORED WITHOUT PLASTIC FOIL. SOME MARKS AND SCRATCHES ARE VISIBLE ON BOX MAYBE DUE TO INSTRUMENT. THERE IS ONE OPENED BLISTER IN BOX. THE OUTER BLISTER NOT RETURNED.THIS EVENT CAN BE CLASSIFIED AS USER RELATED. THE ROOT CAUSE OF COMPLAINT IS MISUSE ON STORAGE CONDITIONS.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT "WHEN OPENING THE DEVICE BEFORE USE FOR A SURGERY, THERE WAS A LOT OF ICE AND THE IMPLANT WAS COMPLETELY FROZEN. IT WAS NOT USED AND ANOTHER DEVICE OF SAME REFERENCE WAS USED FOR THE SURGERY." THE ACCOUNT CONFIRMED THAT ALL IMPLANTS ARE STORED AT THE SAME LOCATION AND ONLY THIS IMPLANT HAD ICE INSIDE THE PACKAGING AND ON THE IMPLANT.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT "WHEN OPENING THE DEVICE BEFORE USE FOR A SURGERY, THERE WAS A LOT OF ICE AND THE IMPLANT WAS COMPLETELY FROZEN. IT WAS NOT USED AND ANOTHER DEVICE OF SAME REFERENCE WAS USED FOR THE SURGERY." THE ACCOUNT CONFIRMED THAT ALL IMPLANTS ARE STORED AT THE SAME LOCATION AND ONLY THIS IMPLANT HAD ICE INSIDE THE PACKAGING AND ON THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40839 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM/0 ANGLE FOR PIP ARTHRODESIS IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH F001440PABI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other