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H3: product analysis: report confirmed.Evaluation determined that there was a broken burr.The likely cause was identified as excessive lateral force during cutting and corrosion on the components.It was also noted that the burr shaft was broken just proximal to the burr head.Significant corrosion was observed on the burr head.Some corrosion was observed on the exposed burr shaft, and the fracture was found to be consistent with a bending fatigue fracture.This regulatory report is being submitted due to a retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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It was reported that tip of the tip of clear view burr broke off while surgeon was using the burr to drill into bone.The broken tip was located removed from the patient and the broken tip plus burr were isolated from the patient and procedure.It was reported that there was no patient impact.It was also reported that there were no adverse events or outcomes for the patient, no delay in surgery and procedure was completed with a backup product.On follow-up the procedure was reported as l2/3 robotically assisted posterior lumbar interbody fusion and there were no fragments left inside the patient, it was confirmed with the health care professional that there was no patient or staff impact.
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