It was reported that during a cori tka procedure, theres bone debris occurring during bone milling of femur and tibia.It was stated that debris was observed flying off sterile field into the air, touching ceiling, lights, equipment, etc.And anesthesia was demanding more coverage and a barrier.Because of these statements, the drape was raised higher and an extra drape was also placed at the head of the patient, as well as a longer clear drape to further drape out anesthesia and equipment.They also found the tower/cart for the bovie covered with some debris after the case.The doctor mills the entire femur and tibia with a combination of exposure and speed mode.They use the suction and irrigation tubing as his technique permits and there is still significant bone debris.There is additional suction used on the field as well as much as possible.No other complications were reported.
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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.
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