Catalog Number 209063 |
Device Problems
Migration or Expulsion of Device (1395); 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 04/17/2017 |
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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The surgeon was completing a total knee arthroplasty procedure using the robotics arm interactive orthopedic system.The grey handle on the mics fell off after tibial resection.
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Manufacturer Narrative
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Reported event: it was reported that the gray handle fell off.Issue was noticed during case, therefore there was no case delay and no patient harm.Device history review: review of device history records indicate (b)(4) devices were manufactured under lot k086c and (b)(4) including 4200983 were accepted into final stock on 09/08/16.Complaint history review: a review of complaints related to parts in lot number k806c, p/n 209063 shows no other complaint related to the failure in this investigation."visual inspection: visual inspection revealed no physical damage of unit.The screw was outside of the unit.Dimensional inspection: dimensional inspection was not completed visual inspection clearly shows the failure of the device.Functional inspection: functional inspection was not completed.Reported problem was with the screw and handle.Conclusions: the screw holds the handle in place.If the screw backs out then the handle can fall.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that (b)(4) and capa (b)(4) are associated with the failure mode reported in this event.".
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Event Description
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The surgeon was completing a total knee arthroplasty procedure using the robotics arm interactive orthopedic system.The grey handle on the mics fell off after tibial resection.
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Search Alerts/Recalls
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