Model Number 219999 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Reported event: an event regarding inaccurate resection involving a mako tka software was reported.The event was not confirmed.Method & results -product evaluation and results: review of the case session files noted the following: the session and vplog data from the case was reviewed.An analysis of the checkpoint check values, registration values, probe check values, rio registration and verification values, bone preparation checkpoints values, and cutting tool location was completed.The data at this time shows that all system verification values were within the accuracy tolerance region; no system defect or malfunction is suspected.The rio cut all five femoral planes on target based on the burr list plane analysis.Upon analyzing the bone registration pattern performed by the doctor, it was found that points were collected properly, resulting in a high registration accuracy.An interesting note about this reported event is that both indicated resections were performed using the angled attachment (distal and posterior chamfer).Always ensure that the blade is fully fixed into the attachment and that the attachment is fully locked into the mics handpiece.A list of best practices has been provided to the mps.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that rob was inspected and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints related to this part number/rob # shows no other similar complaints.Conclusions: based on the analysis of the relevant log files and session files the alleged failure mode was not confirmed.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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After making the distal and posterior chamfer cuts, we used the planar probe on both.Both cuts read as approximately 2-4 mm deep.However, there was no red showing on the cuts to indicate the surgeon had cut past the plan.In addition, we double checked the femur checkpoint and it passed, and we confirmed the set up of the planar probe was correct i.E.The post of the planar probe was touching the inside of the black x.We had to continue on with cuts, and when the trial femur was put on, the surgeon noticed an approximately 1 mm gap between the distal cut and distal part of the implant.The surgeon used bone fragments to fill the gap and still pressfit the femur.Case type / application: tka.
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Manufacturer Narrative
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Reported event: an event regarding inaccurate resection involving a mako tka software was reported.The event was not confirmed.Method & results: product evaluation and results: review of the case session files noted the following: the session and vplog data from the case was reviewed.An analysis of the checkpoint check values, registration values, probe check values, rio registration and verification values, bone preparation checkpoints values, and cutting tool location was completed.The data at this time shows that all system verification values were within the accuracy tolerance region.No system defect or malfunction is suspected.The rio cut all five femoral planes on target based on the burr list plane analysis.Upon analyzing the bone registration pattern performed by the doctor, it was found that points were collected properly, resulting in a high registration accuracy.An interesting note about this reported event is that both indicated resections were performed using the angled attachment (distal and posterior chamfer).Always ensure that the blade is fully fixed into the attachment and that the attachment is fully locked into the mics handpiece.A list of best practices has been provided to the mps.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that the robot was inspected and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a review of complaints shows no other similar complaints.Conclusions: based on the analysis of the relevant log files and session files the alleged failure mode was not confirmed.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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After making the distal and posterior chamfer cuts, we used the planar probe on both.Both cuts read as approximately 2-4 mm deep.However, there was no red showing on the cuts to indicate the surgeon had cut past the plan.In addition, we double checked the femur checkpoint and it passed, and we confirmed the set up of the planar probe was correct i.E.The post of the planar probe was touching the inside of the black x.We had to continue on with cuts, and when the trial femur was put on, the surgeon noticed an approximately 1 mm gap between the distal cut and distal part of the implant.The surgeon used bone fragments to fill the gap and still pressfit the femur.Case type / application: tka.
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Search Alerts/Recalls
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