H3: product analysis found that not able to lock tool in attachment, as lock twist found jammed.Not able to insert the tool into the attachment.Bearings are broken and corroded.Output drive shaft assembly found corroded.Pre-repair temperature test could not be performed.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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