MAKO SURGICAL CORP. MAKOPLASTY® PARTIAL KNEE END EFFECTOR; STEREOTAXIC DEVICE, ROBOTICS
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Catalog Number 111758 |
Device Problems
No Device Output (1435); Non Reproducible Results (4029)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/07/2018 |
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.Pending investigation.
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Event Description
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Anspach was not working when ee trigger was pressed.Switched anspach for a new one and it still did not work.After troubleshooting steps completed, discovered the end effector was not working.Not able to complete the procedure robotically.Any surgical delay? surgical delay of less than 15 min.Was procedure completed manually? yes, when anspach and ee failed to work the case was completed manually.Case type: pka.Update: per the mps, she is not sure if the magnet was missing from the end effector.
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Event Description
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Anspach was not working when ee trigger was pressed.Switched anspach for a new one and it still did not work.After troubleshooting steps completed, discovered the end effector was not working.Not able to complete the procedure robotically.Any surgical delay, surgical delay of less than 15 min.Was procedure completed manually? yes, when anspach and ee failed to work the case was completed manually.Case type: (b)(4).Per the mps, she is not sure if the magnet was missing from the end effector.
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Manufacturer Narrative
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Follow-up #1 and final report submitted.Product identification: the reported device was confirmed to be a makoplasty® partial knee end effector p/n 111758, lot 19460615, s/n (b)(6).Inspection: functional inspection shows the ee was able to turn over the motor up to 80000 rpm and spin it down by releasing the trigger.Product history: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 02/25/2016 with no reported discrepancies.Complaint history review: review of complaints within the trackwise database for p/n 111758, l/n 19460615, s/n (b)(6), show (3) other complaints related to the reported failure.The pr's are 1276702, 1568388, and 1715648.Nc/capa history review: a review of stryker¿s nc/capa database indicated there have been zero ncs or capas associated with the product and failure mode reported in this event.Conclusion: functional inspection shows the ee was able to turn over the motor up to 80000 rpm and spin it down by releasing the trigger.Complaint could not be confirmed.
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Search Alerts/Recalls
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