Catalog Number 110920 |
Device Problems
Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/24/2017 |
Event Type
Injury
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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 partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.The long hd sounded high pitch during burring and heated up enough to burn the surgeon's finger.
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Manufacturer Narrative
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Reported event: the event reported that an anspach hd long attachment loud noise during burring and overheating occurred burning the surgeon's finger.A delay of 10 minutes occurred.Device evaluation and results: the anspach hd long attachment was bench evaluated using a known good anspach motor, anspach foot switch, burr tool and anspach console and all testing successful and the error could not be duplicated.No overheating or audible noise occurred.Device history review: not performed as the anspach hd long attachment is an oem product.Complaint history review: review of complaints for p/n 110920, s/n (b)(4) showed no other complaints within the trackwise database.Conclusion: the failure could not be duplicated.The overheating of the hd long attachment could be due to the anspach motor overheating and transferring thermal energy to the hd long attachment.Corrective action / preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
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Event Description
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The surgeon was completing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system.The long hd sounded high pitch during burring and heated up enough to burn the surgeon's finger.
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Search Alerts/Recalls
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