Catalog Number 209063 |
Device Problems
Output Problem (3005); Complete Loss of Power (4015)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/07/2019 |
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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During mako tka, we had failure of the mics handpiece after the first distal femoral cut.The mics was replaced with another we had on shelf.There was a 20 min delay.Patient's left knee.Primary procedure.
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Manufacturer Narrative
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During mako tka, we had failure of the mics handpiece after the first distal femoral cut.The mics was replaced with another we had on shelf.The product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.A review of the device history records could not be performed as lot code/serial number information was unknown.A review of the complaint history could not be performed as lot code information was unknown.Per (b)(4), preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved, and no actual or potential patient harm existed for the alleged event.The alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.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 nc (b)(4) and capa 1450904.Device not returned.
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Event Description
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During mako tka, we had failure of the mics handpiece after the first distal femoral cut.The mics was replaced with another we had on shelf.There was a 20min delay.Patients left knee.Primary procedure.
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Search Alerts/Recalls
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