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 09/19/2019 |
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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Trials and implants did not appear to be fully seated and cuts (specifically anterior chamfer) appeared to be off.Case type: tka.Update: the only cut that was inaccurate to my knowledge was anterior chamfer.Cuts appeared to be deep.About 2mm discrepancy.Planar probe was utilized on distal and anterior cuts to find cuts were within range.Post op x rays not available.Patient had poor bone quality most likely resulting deep anterior chamfer cut.My goal in this is to rule out a robotic issue.No more pt information available.
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Event Description
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Trials and implants did not appear to be fully seated and cuts (specifically anterior chamfer) appeared to be off.Case type: tka.Update: the only cut that was inaccurate to my knowledge was anterior chamfer.Cuts appeared to be deep.About 2mm discrepancy.Planar probe was utilized on distal and anterior cuts to find cuts were within range.Post op x rays not available.Patient had poor bone quality most likely resulting deep anterior chamfer cut.My goal in this is to rule out a robotic issue.No more pt information available.
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Manufacturer Narrative
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Reported event: an event regarding a inaccurate resection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported that ¿trials and implants did not appear to be fully seated and cuts (specifically anterior chamfer) appeared to be off.¿ it was also reported through a received customer contact that " the only cut that was inaccurate to my knowledge was anterior chamfer.Cuts appeared to be deep.About 2mm discrepancy.Planar probe was utilized on distal and anterior cuts to find cuts were within range.Post op x rays not available.Patient had poor bone quality most likely resulting deep anterior chamfer cut.My goal in this is to rule out a robotic issue.No more patient information available." product evaluation and results: not performed as case session data was not provided.Product history review review of the device history records associated with rio 750 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 complaint record numbers are: (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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Search Alerts/Recalls
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