Model Number 209999 |
Device Problem
Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/04/2019 |
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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On our second mako tka case of the day.The surgeon went to cut the distal femur, the saw check point was off.The mics got contaminated so have to put a new one on.Then we re-done rio registration.All check points passed we went to cut the lateral condyle which was fine and when he cut the medial side he noticed it cut 2 different planes.Checked it with a planor probe and it said 2mm deep.The surgeon wanted to make these a straight cut so proximalised the femur to cut he lateral the corresponding 2mm to make it a straight cut.Went back in all check points passed he noticed again the robot was cutting on 2 different planes.This time it was 5mm deep with the planor probe.At this point he lost his trust in the robot and had to revert to a manual case.He needed distal femur augments to correct this problem but unfortunately the nearest ones were 3 hours away.He waited with patient on the table for implants to arrive.Surgical delay: delay of 5 hours patient had and extended anaesthetic and high risk of infection.**update** the stryker field service engineer re-calibrated the robot and reported that the issue was due to a damaged base array.
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Event Description
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On our second mako tka case of the day.The surgeon went to cut the distal femur, the saw check point was off.The mics got contaminated so have to put a new one on.Then we re-done rio registration.All check points passed we went to cut the lateral condyle which was fine and when he cut the medial side he noticed it cut 2 different planes.Checked it with a plan or probe and it said 2mm deep.The surgeon wanted to make these a straight cut so proxiamlised the femur to cut he lateral the corresponding 2mm to make it a straight cut.Went back in all check points passed he noticed again the robot was cutting on 2 different planes.This time it was 5mm deep with the planor probe.At this point he lost his trust in the robot and had to revert to a manual case.He needed distal femur augments to correct this problem but unfortunately the nearest ones were 3 hours away.He waited with patient on the table for implants to arrive.Surgical delay: delay of 5 hours patient had and extended anaesthetic and high risk of infection.Update: the stryker field service engineer re-calibrated the robot and reported that the issue was due to a damaged base array.
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Manufacturer Narrative
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Reported event: mps reported robot off cutting to 5mm deep.The surgeon reverted to manual.Device evaluation and results: per (b)(4) - details of work performed to address/resolve the service order successfully looked over (b)(6) @ (b)(6) hospital, (b)(6).Carried out kinematic calibration on both left and right sides of robotic arm, checked all transmission cabling j1-j6 all with mako tolerances and specifications.Also carried out hass test to confirm normal functionality of the system.The system is ready for clinical use.Product history review: a review of device history records shows that on (b)(6) 2017 1 device was inspected and 1 device was placed on: qt 17-01-0030.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(6) shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
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Search Alerts/Recalls
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