Model Number 209999 |
Device Problems
Failure to Calibrate (2440); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/30/2019 |
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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Mics failed intra-op and then failed mics status check post-op.Case type: tka.Surgical delay: 30 minutes related pi (b)(4).Update: "we had one replacement and it also failed.We had to complete our final recut manually.".
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Manufacturer Narrative
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Update to b2 and d2.Reported event: it was reported that mics failed intra-op and then failed mics status check post-op.Case type: tka surgical delay: 30 minutes update: "we had one replacement and it also failed.We had to complete our final recut manually." product evaluation and results: mics-209063 sn# (b)(6) lot#42060618 product history review: device history records indicate 25 devices were manufactured and all 25 devices were accepted into final stock on 07/13/2018.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot 42060618 shows 7 additional complaints related to the failure in this investigation.Conclusions: the failure is confirmed via inspection.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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Mics failed intra-op and then failed mics status check post-op.Case type: tka surgical delay: 30 minutes.Related pi 2202453.Update: "we had one replacement and it also failed.We had to complete our final recut manually.".
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Search Alerts/Recalls
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