Model Number 219999 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2021 |
Event Type
malfunction
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Event Description
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As reported via case number.Mps reported inaccurate cuts in multiple cases.Mps confirmed no issues with registration, camera is clean and in a good location.Mps stated the main issue is with the distal femur cut.Case completed robotically.As reported via complaint form: experiencing deep cuts, especially with the distal femoral cut.Robot would not show red on the cut, but when checked with planar probe, the cut would be 2mm or more deep.We have seen cuts as deep as 2.5mm.When trialing cuts were confirmed to in fact be deep.Several times the only deep cut was the distal cut, but we have seen it on others as well.No surgical delay.Case type / application: tka.
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Manufacturer Narrative
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As part of 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.Device not returned.
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Manufacturer Narrative
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Reported event.An event regarding inaccurate resection involving a mako robotic arm was reported.The event was confirmed.Method & results -product evaluation and results: the field service engineer reported: case number: (b)(4), work order: (b)(4).Work performed: reported problem ¿ inaccurate cuts in multiple cases.Observation ¿ j6 transmission cables tension was slightly low but within tolerance.Action taken ¿ tensioned the j6 transmission cable.Performed full pm on the system.All tests passed without error.Arm accuracy passed on both sides.System ready for clinical use.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.A pm service was also performed: the field service engineer reported: case number: (b)(4), work order: (b)(4).Problem reproduced? n/a.Trouble shooting notes: none work performed: pm service is due ¿ completed pm service per pm schedule.Observed ¿ rear j2 bumpstop was slightly out of place.Adjusted ¿ rear j2 bumpstop to optimal range.Replaced ¿ no parts replaced.No other problems observed.All tests are optimal.System ready for clinical use.Work order disposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that (b)(6) was inspected on 01/27/2020 and the quality inspection procedures were completed with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the alleged failure mode was confirmed to be caused by mechanical failure of j2 bump stop and j6 transmission cables as per the fse.Successfully completed all checks, verifications, and calibrations.System is ready for clinical use.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Event Description
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As reported via case number.Mps reported inaccurate cuts in multiple cases.Mps confirmed no issues with registration, camera is clean and in a good location.Mps stated the main issue is with the distal femur cut.Case completed robotically.As reported via complaint form: experiencing deep cuts, especially with the distal femoral cut.Robot would not show red on the cut, but when checked with planar probe, the cut would be 2mm or more deep.We have seen cuts as deep as 2.5mm.When trialing cuts were confirmed to in fact be deep.Several times the only deep cut was the distal cut, but we have seen it on others as well.No surgical delay.Case type / application: tka.
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Search Alerts/Recalls
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