Midas Rex MR8

Description of Event or Problem

It was reported that prior to use, the attachment bearing detached. There was no patient involvement.

Additional Manufacturer Narrative

H3: Product Analysis: Evaluation determined that the distal bearing is detached. The likely cause of failure is due to worn bearings. It was also noted that the laser markings are faded. This regulatory report is being submitted due to retrospective review through CAPA #672570 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.