BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3151285 · Received June 7, 2013

    Report

    Report Number
    0008031020-2013-00175
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K070598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE INVESTIGATION RESULTS IT CAN BE CONCLUDED, THAT THE CORRECT IMPLANT WAS INSERTED DURING SURGERY AND THAT THE SLIGHT DEFORMATION OF THE IMPLANT OCCURRED DURING UNLOADING OUT OF THE HOLDER. THE IMPLANTS ARE OUT OF NITINOL, A SHAPE MEMORY METAL. NITINOL IS A HIGHLY FLEXIBLE METAL, WHICH CAN BE DEFORMED AND WHICH AGAIN GAINS A TRAINED SHAPE AT A CERTAIN TEMPERATURE. FOR IMPLANTS, THE BODY TEMPERATURE RECOVERS THE ORIGINALLY TRAINED SHAPE. THE SHAPE OF THE IMPLANTS IS CREATED MAINLY BY LASER CUTTING. AFTER GAINING THE INITIAL SHAPE, THE PRODUCTS ARE 'TRAINED' TO AGAIN GAIN THE SHAPE AT THE BODY TEMPERATURE. AFTER THAT THE PRODUCTS ARE MECHANICALLY DEFORMED INTO THE IMPLANTATION SHAPE, WHICH IS NARROW IN ORDER TO GET IMPLANTED. AT THE HOSPITAL THE PRODUCTS ARE FROZEN TO RETAIN THE IMPLANTATION SHAPE UNTIL THEY ARE IMPLANTED. WITH THE WARM UP PROCESS TO THE BODY TEMPERATURE, THE IMPLANT UNFOLDS AND GETS ANCHORED IN THE BONE STRUCTURE. EVERY DEFORMATION AFTER THE SHAPE TRAINING PROCESS WILL BE REVERSED, UNLESS NO HIGH DEFORMATION OCCURRED. THUS, THE PROFILE OF THE IMPLANT IN THE BODY WILL DISTINGUISH IF THE PRODUCT WAS DELIVERED ANGLED OR NOT ANGLED. THE FEEDBACK OF THE SURGEON WAS RECEIVED ON (B)(6). THE IMPLANTED DEVICES ARE NON-ANGLED AND NO BUCKLING IS VISIBLE ACCORDING TO THE FUNCTIONALITY OF THE DEVICE AND THE REVERSE DEFORMATION, IT CAN BE CONCLUDED THAT NO MORE THAN 15 MIN PROLONGATION OF SURGERY TIME OCCURRED WITHIN THESE SURGERIES. FOR THE HYPOTHETICAL CASE OF A WRONG IMPLANT DURING SURGERY (ANGLED INSTEAD OF NON- ANGLED VERSION) A PROLONGATION OF SURGERY TIME LESS THAN 15 MINUTES IS EXPECTED. BASED ON THE INVESTIGATION, THIS CASE COULD BE CLASSIFIED AS USER-RELATED. THE DEFORMATION WAS MOST PROBABLY DONE DURING REMOVAL OF IMPLANT FROM THE HOLDER. 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.

    Description of Event or Problem · 1

    THE PHARMACIST ASSISTANT HAS REPORTED THE FOLLOWING, " ON (B)(6) 2013, DURING THE INSTALLATION OF TWO SMART TOE REF ST0-19P STERILE IMPLANTS, THE SURGEON OPENED THE PACKAGE AND FOUND THAT THE IMPLANT WAS A STAPLE AT 10 ° INSTEAD OF 0 °. THIS HAPPENED ON 2 IMPLANTS REQUESTED BY THE SURGEON (SAME BATCH NUMBER: (B)(4))."

    Description of Event or Problem · 1

    THE PHARMACIST ASSISTANT HAS REPORTED THE FOLLOWING, " ON (B)(6) 2013, DURING THE INSTALLATION OF TWO SMART TOE REF (B)(4) STERILE IMPLANTS, THE SURGEON OPENED THE PACKAGE AND FOUND THAT THE IMPLANT WAS A STAPLE AT 10 ° INSTEAD OF 0 °. THIS HAPPENED ON 2 IMPLANTS REQUESTED BY THE SURGEON (SAME BATCH NUMBER: (B)(4))"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252772 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 0° ANGLE FOR PIP ARTHROD IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH F003957PCAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other