BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3056199 · Received April 12, 2013

    Report

    Report Number
    0008031020-2013-00090
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K112197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 DID NOT EXPAND COULD NOT BE CONFIRMED SINCE THE RETURNED DEVICE IS CONFORMING TO SPECIFICATION. THE CORRECTIVE ACTION TAKEN UNDER CAPA (B)(4) TO AVOID BAD EXPANSION FEELING WAS: "IN SURGICAL TECHNIQUE: ADD RECOMMENDATION TO USE OF STERILE SALINE TO GET FULL EXPANSION PRIOR TO SUTURE THE PATIENT." 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°C /32°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°C (98,6°F) TO 40°C (104°F). WE CAN CONCLUDE THE ROOT CAUSE OF THIS COMPLAINT IS RELATED TO USE IF THE DEVICE DID NOT EXPAND ON TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMART TOE COULD NOT BE OPENED. MOREOVER IT WAS REPORTED THAT THE PROXIMAL SHARE OF THE IMPLANT WAS LOOSE PRIMARILY AND HASN'T EXTENDED CORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMART TOE COULD NOT BE OPENED. MOREOVER IT WAS REPORTED THAT THE PROXIMAL SHARE OF THE IMPLANT WAS LOOSE PRIMARILY AND HASN'T EXTENDED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157411 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH F003600PBBR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other