Model Number 112230 |
Device Problems
Mechanical Problem (1384); Misassembly by Users (3133)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/06/2019 |
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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Pelvic array and pelvic array clamp got cross threaded and need to be replaced.Case type: tha.
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Event Description
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Pelvic array and pelvic array clamp got cross threaded and need to be replaced.Case type: tha.
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Manufacturer Narrative
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Reported event: pelvic array and pelvic array clamp got cross threaded and need to be replaced.Product evaluation and results: visual inspection: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the device history records indicate (b)(4) devices were manufactured and (b)(4) were accepted into final stock on 10/26/2011.A review of npr11-10-0116 revealed that the non-conformance is not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112230, lot number 19110711 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 nc and capa associated with the product and failure mode reported in this event.H3 other text : device not returned.
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Search Alerts/Recalls
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