Additional information was provided in sections d.9, h.3, h.6 and h.10.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The handpiece was returned for testing on this investigation.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.The handpiece was received for testing on this investigation.A visual assessment of the returned sample revealed no obvious non-conformities.The handpiece was connected to a calibrated resistance breakout test box, where the connection between the input and output impedance of the sensor was found to be within specifications.The returned sample was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements which found the handpiece to meet specifications.The handpiece passed all required tests thee (3) times with different tips.The handpiece was found to meet specifications.Therefore, the root cause of the reported event is inconclusive.Manufacturer 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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