Catalog Number 209063 |
Device Problems
Computer Software Problem (1112); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/21/2018 |
Event Type
malfunction
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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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The saw blade had errors preventing it from passing at several differing levels.We re-registered several times intra-op as the issue was recurring from attachment straight to angled as well.It successfully registered and then had an error above the 1.5mm again.We swapped out the mics handpiece and then reregistered again for the final two cuts and it worked fine and passed without any sort of error for the final two cuts.This is indicative that the mics was not functioning properly even though it was properly assembled and the attachments were fully secure and in proper alignment to the arm.Our primary concern is why the robot successfully registered and re-registered and verified multiple times without error since the mics was the culprit here.Post-resection at the trialing stage then the cuts were off in areas and the surgeon ended up cementing the femur instead of pressfitting due to the cuts.This is likely due to the play/change in error of the sawblade between first and second cuts and then again after registering until we changed they mics for the final two cuts.Surgical delay 30 min case for this surgeon.Case type: tka.
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Manufacturer Narrative
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Reported event: it was reported that the saw blade had errors preventing it from passing at several differing levels.We re-registered several times intra-op as the issue was recurring from attachment straight to angled as well.It successfully registered and then had an error above the 1.5mm again.Product evaluation and results: as per work order (b)(4) and case number (b)(4) the alleged failure mode was confirmed.Unable to repair mics as with the new cable did not fix the issue.Disposition - (return to vendor).Rtv reason: failed test low warning hall 3.Product history review: device history records indicate (b)(4) devices were manufactured under lot k08mc and (b)94) devices were accepted into final stock on 11/23/2016.A review of qt16-11-0073 revealed that the issue is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to p/n 209063, prodex lot k08mc shows no additional complaint(s) related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that there have been no nc¿s associated with the product and failure mode reported in this event.
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Event Description
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The saw blade had errors preventing it from passing at several differing levels.We re-registered several times intra-op as the issue was recurring from attachment straight to angled as well.It successfully registered and then had an error above the 1.5mm again.We swapped out the mics handpiece and then reregistered again for the final two cuts and it worked fine and passed without any sort of error for the final two cuts.This is indicative that the mics was not functioning properly even though it was properly assembled and the attachments were fully secure and in proper alignment to the arm.Our primary concern is why the robot successfully registered and re-registered and verified multiple times without error since the mics was the culprit here.Post-resection at the trialing stage then the cuts were off in areas and the surgeon ended up cementing the femur instead of pressfitting due to the cuts.This is likely due to the play/change in error of the "saw blade" between first and second cuts and then again after registering until we changed they mics for the final two cuts.Surgical delay 30 min case for this surgeon.Case type: tka.
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Search Alerts/Recalls
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