The company representative was able to replicate the reported event.The footswitch was replaced and returned for testing on this investigation.The system was tested and found to meet product specifications.A non-conformance-based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.A visual assessment of the returned sample revealed that it was missing one fixation screw, the coating had peeled off the sides of the footswitch, and several parts of the footswitch had corroded.The reported event is attributed to a broken wire within the left horizontal toe switch.Based on the information obtained, the root cause of the reported event is attributed to a broken wire within the left horizontal toe switch.How or why this component failed cannot be conclusively determined.Manufacturers will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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