Conclusions: after unsuccessful attempts to retrieve additional information regarding the patient and product return, the reported pin break could not be confirmed.With only the information available, a complaint recreation could not be performed as there was not enough information on how the device was being used on the patient.A sample evaluation was conducted; however, it did not confirm the reported issue as the sample functioned as intended with no issues of components breaking.Furthermore, there were no injuries reported.At this time there is no evidence that a manufacturing non-conformity contributed to the reported issue.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Historical data did not reveal any similar issues in the last 36 months.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.(b)(4).
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