BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD

    MDR report key: 3092553 · Received May 3, 2013

    Report

    Report Number
    0008031020-2013-00134
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K112197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE DEVICE BROKE COULD BE CONFIRMED SINCE X-RAYS SHOWING A BROKEN SMART TOE WERE PROVIDED. IT WAS REPORTED THE PATIENT FELL DOWN CONDUCTING TO THE BREAKAGE. IT WAS ALSO REPORTED THAT THE PATIENT WAS OBESE ((B)(6)) A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING WAS DONE. PLEASE NOTE THAT THE OP TECHNIQUE READS: SMARTTOE IMPLANTS ARE NOT INTENDED FOR IMMEDIATE POSTOPERATIVE WEIGHT BEARING. BE SURE THAT THE POSTOPERATIVE LOADING OF THE INTERNAL FIXATION IS REDUCED TO A MINIMUM (E.G. WITH APPLICATION OF A FOREFOOT OFF-LOADING SHOE) UNTIL BONE CONSOLIDATION IS CONFIRMED. THE CURRENT IFU ALSO READS THAT: FACTORS CAPABLE OF COMPROMISING IMPLANTATION SUCCESS. EXCESS WEIGHT, INTENSE PROFESSIONAL OR SPORTING PHYSICAL ACTIVITY THAT EXPOSES THE IMPLANT TO EXCESSIVE OR REPEATED LOADS. BASED ON THE INVESTIGATION RESULTS THIS CASE COULD BE CLASSIFIED AS USER RELATED. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ACCIDENT , FELL AND SNAPPED SMART TOE IMPLANT. PATIENT WAS REVISED. SURGEON REMOVED SMART TOE AND SUTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ACCIDENT , FELL AND SNAPPED SMART TOE IMPLANT. PATIENT WAS REVISED. SURGEON REMOVED SMART TOE AND SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194943 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH F002347PBAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention