BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3056204 · Received April 12, 2013

    Report

    Report Number
    0008031020-2013-00091
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 18, 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
    UK
    Reporter Occupation
    PHYSICIAN

    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. THE ACTION TAKEN 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." SEE EXTRACT FROM THE OP TECH ATTACHED IN PHASE 3. 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.

    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

    THE CUSTOMER, REPORTED TO THE SALES REP, THAT THE SMART TOE "EYE" DID NOT OPEN WIDE ENOUGH ON THE PROXIMAL SIDE. THE SALES REP REPORTED THAT A REPLACEMENT WAS AVAILABLE BUT THE SURGEON USED A DIFFERENT TECHNIQUE.

    Description of Event or Problem · 1

    THE CUSTOMER, REPORTED TO THE SALES REP, THAT THE SMART TOE "EYE" DID NOT OPEN WIDE ENOUGH ON THE PROXIMAL SIDE. THE SALES REP REPORTED THAT A REPLACEMENT WAS AVAILABLE BUT THE SURGEON USED A DIFFERENT TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157436 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH F003803PBCD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other