Catalog Number 209830 |
Device Problems
Contamination /Decontamination Problem (2895); Non Reproducible Results (4029)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/06/2019 |
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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Impactor continues to contain bi burden after sterilization.Case type: tha.Surgical delay: x = 15 minutes.Update: patient was under anesthesia.
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Manufacturer Narrative
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Reported event: it was reported that the impactor continues to contain bi burden after sterilization.Product evaluation and results: product inspection could not be performed as the product was not available for evaluation.Product history review: review of the product history records indicate 104 devices were manufactured under lot no 34177 and accepted into final stock on 09/23/2016.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209830, lot number 34177 shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.
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Event Description
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Impactor continues to contain bi burden after sterilization.Case type: tha.Surgical delay: x - =15 minutes.Update: patient was under anesthesia.
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Search Alerts/Recalls
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