Zimmer biomet complaint : (b)(4).This final report is being submitted to relay corrected and additional information.Summary: technical review and physical evaluation: subject matter expert log analysis of the reported event, confirmed ¿the femur resection and cut block.But the log do not confirm the tibia resection.The femur over-resection was confirmed by the validation data both on the medial and lateral resection.The over-resection was also confirmed with a caliper measurement.The tibia resection.The logs do not reveal any registered validation data for the tibia cut.The live cut values and the validation tool are visible to the camera toward the end of the resection flow.It is possible that the user saw the validated value and simply did not accept them.Unfortunately, this means the value seen on screen was not recorded in the logs.The cut block would not passing checkpoint validation: technical and physical inspection of the cut block showed crushed threads at one of the two thumbs screws along with excessive wear at the cut slots areas.It was deemed non-conform by the manufacturing team.This could have affected the mounting of the cut block and resulted in the checkpoint failures.Others factors contributed to the reported event: femur and tibia 3mm over-resection: change of orientation of the camera, or change of orientation of the base tracker.The second registration might have been affected by non-optimal mounting of the arm reference, an instability of the robot or camera, preventive maintenance, software and hardware upgrade was performed by a field service technician on (b)(6) 2021, robotic system was tested as per procedure, all tests passed successfully.No device or software issues were found.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause: a precise root cause for reported resections discrepancies cannot be determined.Probable cause is robot base tracker movement.Other potential factors include: damaged or worn cut block; instability of the robot camera; an unusual landmarking section and a movement of the bone tracker; erroneous landmarks on a generic bone model; poor six-point registration; defective validation tool/loose validation tool tracker/validation tool not mounted correctly.A precise root cause for reported checkpoint failure for cut guide cannot be determined.Although the cut guide was found to be damaged through use by zimmer staff, a probable root cause is a movement of robot base tracker.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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