Model Number 206967 |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/05/2019 |
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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Stub on bottom of tha end effector array came off after removal from mako arm (after case).Case type: tha.
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Manufacturer Narrative
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Reported event: it was reported that stub on bottom of tha end effector array came off after removal from mako arm (after case).Product evaluation and results: visual inspection: visual inspection confirms failed locking mechanism.There is oxidation and discoloration on the 202870 slide assembly, 202862 ball retainer.The 202857 dowel pin that locates the 202870 slide assembly has backed out, causing the slide assembly to rotate freely.The 202866 release knob is sheared off.The 111777 locating pin is missing.The 202866 knob and the base have dent marks.The degree markers bears crack/ fracture.See attachments for images of the instrument.Dimensional inspection: dimensional inspection was not completed as visual inspection clearly shows the failure of the device.Functional inspection: functional inspection as not completed as visual inspection clearly shows the failure of the device.Material analysis: material analysis was completed as part of the root cause investigation of capa 1450905.Product history review: review of the device history records indicate (b)(4) devices were manufactured and (b)(4) accepted into final stock on 11/28/2016.Review of qt 16-11-0080 revealed that (b)(4) devices were accepted into final stock on 08/23/2019.The non conformance is not related the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 206967, lot number 19530615 shows 5 additional complaints related to the failure in this investigation.The complaints are (b)(4).Conclusions: the failure is confirmed via visual 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 an nc and capa associated with the product and failure mode reported in this event.This is nc (b)(4) & capa 1450905.
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Event Description
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Stub on bottom of tha end effector array came off after removal from mako arm (after case).Case type: tha.
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Search Alerts/Recalls
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