Model Number 209999 |
Device Problems
Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 01/22/2021 |
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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During mako tka, the surgeon noticed a crack on the tibia after cutting it, but he continued procedure, then a fracture occurred at ap face when keel was punched.It was fixed by using soft wire, fixed the keel by chisel and implanted and closing the incision.The surgeon wanted to know the root cause of the event, whether it was because mako procedure, aggressive use of kocher to pull the bone or forced pulling tibia to avoid medial exfoliation.
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Event Description
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During mako tka, the surgeon noticed a crack on the tibia after cutting it, but he continued procedure, then a fracture occurred at ap face when keel was punched.It was fixed by using soft wire, fixed the keel by chisel and implanted and closing the incision.The surgeon wanted to know the root cause of the event, whether it was because mako procedure, aggressive use of kocher to pull the bone or forced pulling tibia to avoid medial exfoliation.
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Manufacturer Narrative
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Reported event: an event regarding inaccurate resection involving an unknown mako robot/tka software was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records could not be performed as the device was not properly identified.Complaint history review: a review of complaints in trackwise could not be performed as the device was not properly identified.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as the catalogue number, robot number and return of the case session/log data are needed to complete the investigation for determining root cause.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text: device not available.
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Search Alerts/Recalls
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