Biopsy Guide

Additional Manufacturer Narrative

H3, H6: No products have been returned to Medtronic for analysis. Codes B17, C20, and D15 are applicable. 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.

Description of Event or Problem

Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that a biopsy guide (Precision Aiming Device), at the proximal screw where it mounted to the articulating arm, was not able to be tightened down. It was reported that the biopsy guide continued to rotate despite attempts to lock it into position because the screw would not tighten and the guide could not be locked or held in position. There was no patient involved.