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Catalog Number 209999 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/28/2017 |
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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Completed unicompartmental case.Surgeon bumped base array with patient's leg when flexing leg.Re-registration of the rio was required.Completed second registration successfully and returned to bone prep.Conducted ct view check, passed.Bone prep completed.When surgeon placed the femoral trial on the femur, the resected bone area did not match the trial perfectly.The post holes seemed to be off center.The doctor proceeded to forcefully impact the femur into the holes.This led to a small crack in the femoral condyle.Surgeon utilized a cancellous bone screw to repair the crack and completed manual burring with manual instrumentation before implanting final implant.Plans, logs, etc., uploaded to the complaints folder in folder named "(b)(6)." case type: pka, surgical delay: 15 minutes.
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Manufacturer Narrative
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Reported event: an event regarding inaccurate femoral placement involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 482 found quality inspection procedures successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding inaccurate femoral placement.There were only 5 other reported events ((b)(4)).Conclusion: case x-rays were requested, but are not available for review.The session and vplog data from the case was reviewed.An analysis of the checkpoints values, bone registration values, rio registration values, and bone preparation checkpoint values was completed.The data at this time shows all system verification values were within tolerance; the mako operated as expected.No system defect or malfunction is suspected.
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Event Description
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Completed unicompartmental case.Surgeon bumped base array with patient's leg when flexing leg.Re-registration of the rio was required.Completed second registration successfully and returned to bone prep.Conducted ct view check, passed.Bone prep completed.When surgeon placed the femoral trial on the femur, the resected bone area did not match the trial perfectly.The post holes seemed to be off center.The doctor proceeded to forcefully impact the femur into the holes.This led to a small crack in the femoral condyle.Surgeon utilized a cancellous bone screw to repair the crack and completed manual burring with manual instrumentation before implanting final implant.Plans, logs, etc., uploaded to the complaints folder in folder named ¿(b)(6)¿.Case type: pka.Surgical delay: 15 minutes.
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Search Alerts/Recalls
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