Model Number 209999 |
Device Problems
Positioning Failure (1158); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2021 |
Event Type
malfunction
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Event Description
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During bone prep of right leg, surgeon measured depth of distal cut with green probe and found it was 1.6 deep on both medial and lateral side.No red was visible on bone resection screen.Patient was hyperextended due to extra bone cut and a size 11 implant was used to correct.Case completed manually.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.
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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 not confirmed because the product was not available for inspection.Method & results product evaluation and results: review of the case session files was not performed as case session data was not available.The log files provided by the mps were not made accessible for review.The following was noted from a previous case where inaccurate cuts were also alleged problem reproduced? no.Trouble shooting notes: none.Work performed: the customer chose to not have us come out for the system because it was surgeon error.Work order disposition: not required.No additional requests have been made for a field service engineer to inspect the robot for this event.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob100 was inspected and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints related to p/n 209999, robot number: rob100 shows 5 similar complaints for robotic arm - inaccurate resection.Conclusions: the alleged failure mode was not confirmed as there has been no onsite inspection by a field service engineer.If a field service inspection is requested, further investigation will be completed on this issue.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.H3 other text : not available.
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Event Description
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During bone prep of right leg, surgeon measured depth of distal cut with green probe and found it was 1.6 deep on both medial and lateral side.No red was visible on bone resection screen.Patient was hyperextended due to extra bone cut and a size 11 implant was used to correct.Case completed manually.Case type / application: tka.
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Search Alerts/Recalls
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