It was reported that, during the cut of tibia in a cori assisted surgery, surgeon cut an unintended soft tissue and lost the control of the drill.As a result of this, caused damage to the patient skin.The patient was recovered to suture the wound.This procedure was completed, with a delay of less than 30 min.
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Section h3, h6.: the real intelligence cori, part number rob10024, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.The clinical/medical investigation concluded that the suspected ¿technical error¿/user variance is most likely the root cause of the reported events.The user manual does warn to use soft tissue retractors, software only tracks operative bone/avoid tissues not intended to be cut, and to use slow, methodic ¿plunge and drag motion¿ avoiding quick passes or ¿feathering¿ the tool over the surface.The patient impact beyond the reported soft tissue and skin lacerations, subsequent suture repair and 0-30 minute surgical extension could not be determined.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to performing total knee arthroplasty (tka): removing bone during tka section of the user manual for knee arthroplasty (500230 rev d).For easily accessible areas unrestricted by boney anatomy, (i.E., bur all techniques for tka and bi-cruciate knee replacement) utilizing exposure control mode with the bur working perpendicular to the cutting surface is recommended.For regions that have limited access such as posterior femur and tibia, utilization of speed control mode is a more efficient preparation method.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with the surgical technique.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.H6: health effect - clinical code.
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