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Model Number 209999 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/21/2019 |
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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Case number: (b)(4) - mps (b)(6) reported inaccurate tka cuts and 'auto arm accuracy' failure.Case type: tka.Update: "any surgical delay? yes, <1hr.Was the case cancelled? no.Was procedure completed successfully? yes.Was procedure completed manually? no - we already made all cuts.Which cuts were inaccurate? system showed all cuts were accurate.How was the cut inaccurate? our system showed all cuts were accurate.What is the estimated discrepancy mentioned in the complaint? (pka - mm) planned for 18mm ending up being 25degrees hyper extended and 28mm gaps.Planned for a 9 poly and ended up putting in a 19.When was the issue noticed (bone preparation or joint assessment)? after bone cuts.Was the planar probe utilized to measure cut accuracy? yes.Are post-op x-rays available? no.".
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Manufacturer Narrative
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Reported event: an event regarding an inaccurate resection involving 3.0 rio® robotic arm mics, catalog: 209999 was reported.It was reported that ¿case number: (b)(4), (b)(6); mps reported inaccurate tka cuts and 'auto arm accuracy' failure.How was the cut inaccurate? our system showed all cuts were accurate.What is the estimated discrepancy mentioned in the complaint? (pka - mm), planned for 18mm ending up being 25degrees hyper extended and 28mm gaps.Planned for a 9 poly and ended up putting in a 19.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Field engineer reported: case number: (b)(4), work order: 9b)(4).Problem reproduced? no.Work performed: adjust j4 slightly to bring warning to pass.Clean camera lens, clean hybrid cable connections.Work order deposition: system investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: review of the device history records associated with rio 745 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn: 209999 reports similar complaints for tka software / inaccurate resection.The complaints are pr: (b)(4) conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.Corrective action/preventive action: a search of the nc / capa database under device identification pn: 209999 reports no records related to tka software / inaccurate resection.
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Event Description
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Case number: (b)(4), (b)(6); mps (b)(6) reported inaccurate tka cuts and 'auto arm accuracy' failure.Case type: tka.Update: "any surgical delay? yes, 1hr.Was the case cancelled? no.Was procedure completed successfully? yes.Was procedure completed manually? no, we already made all cuts.Which cuts were inaccurate? system showed all cuts were accurate.How was the cut inaccurate? our system showed all cuts were accurate.What is the estimated discrepancy mentioned in the complaint? (pka - mm).Planned for 18mm ending up being 25degrees hyper extended and 28mm gaps.Planned for a 9 poly and ended up putting in a 19.When was the issue noticed (bone preparation or joint assessment)? after bone cuts.Was the planar probe utilized to measure cut accuracy? yes.Are post-op x-rays available? no.
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Search Alerts/Recalls
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