The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis - the review of the historical data was performed.Trend analysis- the overall complaint trend data for the period aug-19 to jul-21 was reviewed.Communication/interviews: communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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