Catalog Number 110940 |
Device Problems
Electrical /Electronic Property Problem (1198); Temperature Problem (3022)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2016 |
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 performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During the case the anspach burr motor malfunctioned.The anspach motor was exchanged with a replacement anspach motor, which then also malfunctioned.The motor was exchanged for a third replacement motor.The case was then completed successfully with a 15 min case delay.
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Manufacturer Narrative
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Follow-up #1 and final report submitted to update sections based on the results of investigation.Reported event: anspach emax 2 plus burr motor overheating errors.Method & results: device evaluation and results: device evaluation was performed and the anspach emax 2 plus burr motor event was confirmed.Device history review: not performed as the anspach emax 2 plus burr motor is an oem product.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding overheating error failure of p/n: 110940, s/n: (b)(4).There have been no other similar events for the referenced serial number.Trend request for this part number has been submitted (trend request #(b)(4)).Conclusions: the anspach emax 2 plus burr motor is an oem device.Upon receipt, the anspach emax 2 plus burr motor was bench evaluated by (b)(6) and the reported event was confirmed.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.Trend request #(b)(4) has been initiated to continue to monitor for events related to this device.
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Event Description
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The surgeon was performing a partial knee arthroplasty using the robotic arm interactive orthopedic system (rio).During the case the anspach burr motor malfunctioned.The anspach motor was exchanged with a replacement anspach motor, which then also malfunctioned.The motor was exchanged for a third replacement motor.The case was then completed successfully with a 15 min case delay.
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Search Alerts/Recalls
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