It was reported that during a surgical procedure, there were homing failures.Troubleshooting was applied but the handpiece had to be changed.It is unknown the length of the surgical delay.No patient injuries reported.Results of the investigation have concluded that the snaplock assembly was damaged, which makes it a reportable event.
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H10: the navio handpiece (part number unknown / serial number unknown), intended for use in treatment, had homing failure during a procedure on (b)(6) 2015.The navio handpiece was not returned for further evaluation and a visual/functional inspection could not be performed.During an internal analysis, the problem was determined to most likely be caused by the material used to manufacture one of the snap lock components.The material used by one of the suppliers is displaying properties after autoclave sterilization that can cause the snap lock assembly to become tight.The root cause of this issue was found to be undetermined.A device history record review was not performed since there was no part/serial/lot number provided and it could not be concluded if the device met the manufacturing specifications.A complaint history review found similar reports and this issue will continue to be monitored.
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