It was reported that, during cori tka procedure, surgeon went to make adjustments to his cut plan.As soon as changes were made, they were prompted with the an unexpected pfs error.The only option was to ¿quit¿ they proceeded to quit this case.They were able to complete the case with no issues.Delay less than 30 minutes reported.The patient is healthy, was not harmed.
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H3, h6: the real intelligence robotic drill, part number rob10013, serial unknown and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation, or field service report.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is internal wiring failure within drill cable.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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