Catalog Number 209063 |
Device Problems
Power Problem (3010); Non Reproducible Results (4029)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/04/2019 |
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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Mics failed during cutting.Then failed during mics ststus check.16-30 minutes surgical delay.Case type: tka.
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Manufacturer Narrative
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Reported event: mics failed during cutting.Then failed during mics status check.16-30 minutes surgical delay.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: device history records indicate (b)(4) devices were manufactured under lot k0ajx and 24 devices were accepted into final stock on 12/9/17.A review of qt17-12-0027 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 k0ajx shows 09 additional complaint(s) related to the failure in this investigation.Complaint pr: (b)(4).Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is (b)(4) and capa 1450904.
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Event Description
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Mics failed during cutting.Then failed during mics ststus check.16-30 minutes surgical delay.Case type: tka.
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Search Alerts/Recalls
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