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 05/08/2019 |
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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Case number: (b)(4), mps (b)(6) reported mics not getting power once in haptics.Case type: tka.Surgery was not completed robotically.Update: "< 30 min surgical delay.Procedure completed manually, last 2 angled cuts were done manually.
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Manufacturer Narrative
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Reported event: mics not getting power once in haptics.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: device history records indicate (b)(4) devices were manufactured under lot kompy and (b)(4) devices were accepted into final stock on 09/05/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints related to p/n 209063 in prodex lot kobpy shows 01 additional complaint(s) related to the failure in this investigation.Complaint (b)(4).Conclusions: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that nc 1414517 and capa 1450904 are associated with the failure mode reported in this event.
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Event Description
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Case number: (b)(4), mps (b)(6) reported mics not getting power once in haptics.Case type: tka.Surgery was not completed robotically.Update: "< 30 min surgical delay.Procedure completed manually, last 2 angled cuts were done manually.
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Search Alerts/Recalls
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