MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INST 960-717 ADJ DRILL STOP, 3.2MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	960-717
Medical Device Problem Codes	Material Deformation (2976); Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable at this time as the lot number is unknown.No parts have been received by the manufacturer for evaluation as they were discarded at the site.No parts returned for analysis.
Event or Problem Description
A medtronic representative reported that while outside of a procedure, an instrument on the navigation system was damaged.The driver tip was worn out and could no longer screw the clamp tightly.There was no patient present when this issue was observed.
Additional Manufacturer Narrative
Device code was corrected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INST 960-717 ADJ DRILL STOP, 3.2MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7246076
• Report Number: 1723170-2018-00551
• Device Sequence Number: 16430610
• Product Code: HAW
• UDI-Device Identifier: 00763000055387
• UDI-Public: 00763000055387
• Combination Product (Y/N): N
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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: 960-717
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1