Please note correction to sections d9/h3 the product was returned, and h6 (method, results and conclusion codes).The reported event could not be confirmed, since the returned device was found to be fully functional and conforming to specifications.The device inspection revealed the following: the visual inspection showed that the implant is in a good state.No signs of damage were noticed.A functional inspection was held.The returned device was found to be conforming to specifications and fully functional.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.General aspect: ¿the smart toe has to be stored at 0°c (32°f) or below for 2 hours or more prior to implantation.The implant has to be taken out of the freezer only after site preparation is complete and ready for implantation.¿ based on the above investigation, most likely the issue is user related since no manufacturing related deficiencies were found.Although a real root cause couldn¿t be determined with the available information.
|