Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The device was received for evaluation.The device was reviewed.Visual inspection reveals that the levers are broken off the valves.The o-ring was also missing from the outer sleeve.This complaint can be confirmed.There was no information provided on the missing o-ring, but it could have fallen off during the sterilization process.The thumb screws were removed from the valves and the out-flow valve is frozen in the device and could not be removed.The in-flow valve was able to be removed and there was no evidence of lubricant.The ifu instructs the users to add a lubricant after the device is sterilized.Improper maintenance is the probable root cause of this complaint.A manufacturing record evaluation was performed for the finished device [151001] number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history a manufacturing record evaluation was performed for the finished device [151001] number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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