G3, h2, h3, and h6: the product, ri robotic drill, rob10013, used for treatment was not returned for evaluation.Thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.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.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, factors that may have contributed to the reported symptom may be associated with improper assembly of tubing resulting in inadequate irrigation and suction, failure to clear surfaces of residual debris using irrigation, suction and/or hand tool orientation with respect to bone surface, limiting debris.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.D10/d11: concomitant medical products: add concomitants.
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