BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3007524 · Received March 15, 2013

    Report

    Report Number
    0008031020-2013-00055
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K112197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE IMPLANT DID NOT EXPAND COULD NOT BE CONFIRMED SINCE THE RETURNED DEVICE IS CONFORMING TO SPECIFICATION. THEREFORE, THE CASE COULD BE CLASSIFIED AS A NON ISSUE. WITH THE LABELING REVIEW, IT WAS VERIFIED THAT THE OP TECH READS: IMPLANTS ARE DELIVERED STERILE - THEY NEED TO BE PLACED IN THE FREEZER (0 DEGREES C /32 DEGREES F, OR BELOW) FOR 2 HOURS OR MORE PRIOR TO IMPLANTATION. NOTE: TO FACILITATE THE SHAPE MEMORY PROCESS, THE PHALANGES CAN BE BATHED IN A WARM STERILE SOLUTION, BETWEEN 37 DEGREES C (98.6 DEGREES F) TO 40 DEGREES C (104 DEGREES F). WE CAN CONCLUDE THE ROOT CAUSE OF THIS COMPLAINT IS RELATED TO USE. THERE IS NO SIMILAR COMPLAINT REPORTED WITHIN THE SAME LOT NUMBER. ONE DEVIATION FROM THE SPECIFICATION WAS NOTED BUT NOT RELATED TO THE REPORTED FAILURE (FOREIGN BODIES ON 2 PARTS AFTER STERILIZATION, 2 NON CONFORM DEVICES WERE SCRAPPED (B)(4)).

    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

    SURGEON SAID THE SMART TOE DID NOT FUNCTION PROPERLY. THEY OPENED ANOTHER ONE AND THAT ONE WORKED FINE.

    Description of Event or Problem · 1

    SURGEON SAID THE SMART TOE DID NOT FUNCTION PROPERLY. THEY OPENED ANOTHER ONE AND THAT ONE WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109822 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH F003279PBBM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other