Model Number 219999 |
Device Problems
Application Program Problem: Parameter Calculation Error (1449); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2022 |
Event Type
malfunction
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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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Event Description
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Case number:(b)(4): mps reported consistently inaccurate tka cuts.Majority of cases for the last month have had significantly deep cuts (1.5-1.8mm) on the distal femur and tibia cuts.Multiple experienced mako surgeons are observing this phenomenon.These surgeons used the planar probe to assess the accuracy of cuts during 'bone preparation' and all cuts except for distal femur and tibia cuts are on plan.Mps also noted that the system isn't showing red for deep cuts, which it should if cuts are 1.5mm+ deeper than intended.Mps confirmed that these issues weren't the result of any bumped arrays or moved checkpoints.Case completed robotically.
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Manufacturer Narrative
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Reported event.Case number: mps reported consistently inaccurate tka cuts.Majority of cases for the last month have had significantly deep cuts (1.5-1.8mm) on the distal femur and tibia cuts.Multiple experienced mako surgeons are observing this phenomenon.These surgeons used the planar probe to assess the accuracy of cuts during 'bone preparation' and all cuts except for distal femur and tibia cuts are on plan.Mps also noted that the system isn't showing red for deep cuts, which it should if cuts are 1.5mm+ deeper than intended.Mps confirmed that these issues weren't the result of any bumped arrays or moved checkpoints.Case completed robotically.Method & results.-product evaluation and results: as per case.Problem reproduced? no.Work performed.Reported problem ¿ mps reported inaccurate tka cuts.Observation ¿ unable to reproduce.Action taken ¿ started with pre-surgery check, registered rio, performed saw-bone distal cut.Cut was optimal.Performed kinematic calibration.Cleaned camera lens system ready for clinical use.Work order deposition.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 rob1084 was inspected and the quality inspection procedures were completed with no reported discrepancies.-complaint history review: there have been 1 other similar events for the lot referenced.Conclusions: the alleged failure mode was not reproduced through an onsite inspection carried out by a field service engineer however the system was optimized for clinical use.Additionally, a complaint history review provides no indication of any inherent software/ hardware issue.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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Case number: (b)(4): mps reported consistently inaccurate tka cuts.Majority of cases for the last month have had significantly deep cuts (1.5-1.8mm) on the distal femur and tibia cuts.Multiple experienced mako surgeons are observing this phenomenon.These surgeons used the planar probe to assess the accuracy of cuts during 'bone preparation' and all cuts except for distal femur and tibia cuts are on plan.Mps also noted that the system isn't showing red for deep cuts, which it should if cuts are 1.5mm+ deeper than intended.Mps confirmed that these issues weren't the result of any bumped arrays or moved checkpoints.Case completed robotically.
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Search Alerts/Recalls
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