BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3844594 · Received June 3, 2014

    Report

    Report Number
    0008031020-2014-00267
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K112197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT SMART TOE IMPLANT HAD NO EXPANSION DURING SURGERY COULD NOT BE CONFIRMED SINCE THE RETURNED DEVICE IS CONFORMING TO SPECIFICATION. THEREFORE, THE CASE COULD BE CLASSIFIED AS A NON-ISSUE. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED NO EXPANSION PROBLEM WAS ATTRIBUTED TO A USER RELATED ISSUE. THE SMART TOE IMPLANT EXPANSION PROBLEM WAS CAUSED BY MISMANAGEMENT OF THE TEMPERATURE. WHEN THE BLOOD IS ARRESTED FOR A LONG PERIOD, THE SMART TOE CAN TAKE LONGER TO EXPAND BECAUSE THE TEMPERATURE OF THE BODY IS TOO LOW. USING WARM STERILE SOLUTION BETWEEN 37°C AND 40°C TO BATH PHALANGES ALLOWS THE SMARTTOE IMPLANT TO EXPAND PROPERLY. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY DOCTOR IMPLANTED SMART TOE, METAL DID NOT EXPAND IN CANAL WITHIN A REASONABLE TIME FRAME. DOCTOR THEN IMPLANTED LARGER SIZE WHICH LED TO A DELAY IN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY DOCTOR IMPLANTED SMART TOE, METAL DID NOT EXPAND IN CANAL WITHIN A REASONABLE TIME FRAME. DOCTOR THEN IMPLANTED LARGER SIZE WHICH LED TO A DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323958 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO PIN, FIXATION, SMOOTH HTY STRYKER TRAUMA SELZACH F004869PCBQ

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other