BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3027427 · Received March 29, 2013

    Report

    Report Number
    0008031020-2013-00076
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K070598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PACKAGING IS EMPTY. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. IN THE SURGICAL TECHNIQUE : ADD RECOMMENDATION TO USE 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 USER. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. PLEASE NOTE THAT MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IT ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE IMPLANT DID NOT EXPAND COULD NOT BE CONFIRMED SINCE THE RETURNED PACKAGING IS EMPTY. THE IMPLANT WAS CONFIRMED LOST DURING SHIPMENT. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. ADD RECOMMENDATION TO USE OF STERILE SALINE TO GET FULL EXPANSION PRIOR TO SUTURING 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 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. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. PLEASE NOTE THAT MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISTAL HOOKLETS DIDN'T OPEN - NO LOCKING. THERE WAS A DELAY OF 3 MIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISTAL HOOKLETS DIDN'T OPEN - NO LOCKING. THERE WAS A DELAY OF 3 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130297 INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 16MM / 0° ANGLE FOR PIP ARTHROD IMPLANT HTY STRYKER OSTEOSYNTHESIS-SELZACH F000859PAAW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other