Model Number 209999 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Malposition of Device (2616)
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Patient Problem
Ambulation Difficulties (2544)
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Event Date 09/28/2020 |
Event Type
Injury
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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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Event Description
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Case number: (b)(6): last 3 cases have resulted in notching.Mps reviewed all 3 plans after case completion and confirmed that the notching issues weren't related to the planned implant placement, patient anatomy (i.E., scan date versus surgery date), robot's inherent error of 2mm/2degrees, etc.I confirmed with the mps that all pre-surgery checks passed prior to each case.
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Manufacturer Narrative
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Reported event: an event regarding inaccurate resection and software error involving a mako tka software was reported.The event was not confirmed.Method & results: -product evaluation and results: review of the case session files was not performed as case session data was not provided.The field service engineer reported: problem reproduced? no.Trouble shooting notes: none.Work performed: no issues found, rerun homing constants and re calibrated.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 31 aug 2016 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: (b)(6) shows 2 similar complaints for tka software - inaccurate resection.Conclusions: the alleged failure mode was not confirmed.Additional information such as return of the crisis logs, patients session files, post op follow up notes and post op x-rays.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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Case number: (b)(4): last 3 cases have resulted in notching.Mps reviewed all 3 plans after case completion and confirmed that the notching issues weren't related to the planned implant placement, patient anatomy (i.E., scan date versus surgery date), robot's inherent error of 2mm/2degrees, etc.I confirmed with the mps that all pre-surgery checks passed prior to each case.
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Search Alerts/Recalls
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