BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO

    MDR report key: 3092550 · Received May 3, 2013

    Report

    Report Number
    0008031020-2013-00133
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K112197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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: THE REPORTED EVENT THAT THE IMPLANT EXPANDED TOO EARLY COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. (EMPTY BOX) A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. PLEASE NOTE THAT THE CURRENT OP TECHNIQUE READS: THE IMPLANT HAS TO BE STORED UNDER 0°C (32°F) FOR A MINIMUM OF 2 HOURS BEFORE IMPLANTATION. THE IMPLANT HAS TO BE TAKEN OUT OF THE FREEZER ONLY AFTER SITE PREPARATION IS COMPLETE AND READY FOR IMPLANTATION. THE IMPLANT IS DESIGNED TO RECOVER ITS SHAPE PROGRESSIVELY AFTER IMPLANTATION, TO ADAPT ITS OPENING TO PATIENT ANATOMY. BASED ON INVESTIGATION RESULTS, THIS CASE COULD BE CLASSIFIED AS USE RELATED. A MISMANAGEMENT OF THE TEMPERATURE SHOULD BE THE ROOT CAUSE OF THE EVENT. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    A SMART TOE IMPLANT REF # (B)(4) EXPANDED TO QUICKLY, BEFORE IMPLANTATION. PROCEDURE WAS COMPLETED SUCCESFULLY WITH ANOTHER IMPLANT.

    Description of Event or Problem · 1

    A SMART TOE IMPLANT REF # (B)(4) EXPANDED TO QUICKLY, BEFORE IMPLANTATION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194942 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH F003278PBBM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other