MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIT 3MM-UC DRILL GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	960-524
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number, unavailable.Device manufacturing date is dependent on lot number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
Medtronic received information that a site nurse discovered a damaged drill bit while washing after a procedure.No additional information was provided.

• Brand Name: BIT 3MM-UC DRILL GUIDE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7481730
• Report Number: 1723170-2018-01852
• Device Sequence Number: 334023
• Product Code: HAW
• UDI-Device Identifier: 00763000055349
• UDI-Public: 00763000055349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 960-524
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1