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Model Number 209999 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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Case number: 04266824, (b)(4) - mps (b)(6) reported femur cuts off.Case type: tka.Update: "upon cleaning out the joint after making straight cuts on the femur, the surgeon stated that the femur was notching.We checked our cut with the planar probe, and we were within the tolerance of accuracy (showed under 1.0 deg/mm).We validated that registration was good when we changed to the angled blade for the last 2 femoral cuts.The software allowed us to go into the distal femur cut upon checking the ¿checkpoint¿ (note: no check points were used.The surgeon picks a spot on the femoral array clamp and uses that as his check point¿off label)." which cuts were inaccurate? anterior femur cut.How was the cut inaccurate? notching (deep) (warning notching 3 degrees away from being present).What is the estimated discrepancy ? 2-3 degrees.Planar probe was used and it showed that we were accurate (under 1mm) to the cut.
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Manufacturer Narrative
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Reported event: an event regarding implant notching involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported ¿case number: (b)(4), mps (b)(6) reported femur cuts off.Upon cleaning out the joint after making straight cuts on the femur, the surgeon stated that the femur was notching.We checked our cut with the planar probe, and we were within the tolerance of accuracy (showed under 1.0 deg/mm).We validated that registration was good when we changed to the angled blade for the last 2 femoral cuts.The software allowed us to go into the distal femur cut upon checking the ¿checkpoint¿ (note: no check points were used.The surgeon picks a spot on the femoral array clamp and uses that as his check point off label).¿ further details provided through customer contact stated; which cuts were inaccurate? anterior femur cut.How was the cut inaccurate? notching (deep) (warning notching 3 degrees away from being present).What is the estimated discrepancy ? 2-3 degrees.Planar probe was used and it showed that we were accurate (under 1mm) to the cut.Method & results: product evaluation and results: the problem statement for this complaint investigation was regarding the system failing to prevent the anterior cut to be prepared deeper than planned, resulting in a notch on the femur.Upon investigating, it may be concluded that the femoral array was sub-optimally set up as indicated in the complaint description and by high checkpoint error values from the logs.Suboptimal array set up is deemed as the root cause of the anterior cut resulting in a notch on the femur.As per work order number: (b)(4), case number: (b)(4).Problem reproduced? yes.Work performed.Realigned the j2 bump stop angles to the factory settings.Successfully performed all verification testing following the service manual.Deposition.System investigation completed successfully as per service manual.All system checks and tests passed; system is ready for use.Product history review: review of the device history records associated with rio 640 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn (b)(6) reports similar complaints for tka software inaccurate resection.The complaint record numbers are: (b)(4).Conclusions: the problem statement for this complaint investigation was regarding the system failing to prevent the anterior cut to be prepared deeper than planned, resulting in a notch on the femur.Upon investigating, it may be concluded that the femoral array was sub-optimally set up as indicated in the complaint description and by high checkpoint error values from the logs.Suboptimal array set up is deemed as the root cause of the anterior cut resulting in a notch on the femur.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, 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 tha software inaccurate resection.
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Event Description
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Case number: (b)(4), mps (b)(6) reported femur cuts off.Case type: tka.Update: "upon cleaning out the joint after making straight cuts on the femur, the surgeon stated that the femur was notching.We checked our cut with the planar probe, and we were within the tolerance of accuracy (showed under 1.0 deg/mm).We validated that registration was good when we changed to the angled blade for the last 2 femoral cuts.The software allowed us to go into the distal femur cut upon checking the ¿checkpoint¿ (note: no check points were used.The surgeon picks a spot on the femoral array clamp and uses that as his check point off label)." which cuts were inaccurate? anterior femur cut.How was the cut inaccurate? notching (deep) (warning notching 3 degrees away from being present).What is the estimated discrepancy ? 2-3 degrees.Planar probe was used and it showed that we were accurate (under 1mm) to the cut.
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Search Alerts/Recalls
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