(b)(6) stated that during the tibia cut, damage to the anterior portion of the mcl occurred.Boundaries were not expanded and some green resection volume was left on the medial portion of the cut.Case type: tka.Update: "retraction technique: mako tkr retractors, noticed during trailing, anterior mcl damage, mako standard saw blade used.".
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Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation."reported event: an event regarding inaccurate resection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: review of the device history records associated with rio 262 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history: a search of the complaint database under device identification pn 209999 reports similar complaints for tka software - inaccurate resection.The complaint record numbers are: (b)(4).Conclusion: the case files provided (crisis logs and patient session file) were reviewed.Areas of investigation included the implant plan, checkpoints, robot registration, bone registration, boundaries, cutting tool history, and service record.All quality metrics pertaining to robot and bone registration and verification were within specification.A review of the tool excursion during the tibia resection showed that the cutting tool did not exit the bone medially or near the probable attachment location of the mcl during tibia preparation.Sips were constrained within the haptic boundary during the tibia cut, with a maximum medial tool excursion of 0.65mm beyond the haptic boundary.The haptic boundary profiles are designed to protect soft tissue structures.Soft tissue retraction is not monitored by the mako system.Additional potential sources of soft tissue damage are manual instrumentation or failure to retract soft tissue.The data at this time shows that the mako system operated within specification.No system defect or malfunction is suspected." no additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to tka software - inaccurate resection.
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Dr.(b)(6) stated that during the tibia cut, damage to the anterior portion of the mcl occurred.Boundaries were not expanded and some green resection volume was left on the medial portion of the cut.Case type: tka.Update: " retraction technique: mako tkr retractors, noticed during trialing, anterior mcl damage, mako standard saw blade used.".
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