MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST 960-521 UC DRILL GUIDE; INSTRUMENT, STEREOTAXIC

Model Number	960-521
Medical Device Problem Codes	Imprecision (1307); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The instrument was not returned, so no analysis was conducted.Refer to mdr 1723170-2019-00317 for the report on the teratracker.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an imaging device being used outside a procedure.The issue occurred during instrument verification of the tracker and the drill guide.It was reported that the two devices were not completely compatible.The product was not completely matched to the naked eye, not to mention the screw fixation, so it would be inaccurate.There was a problem with the product process, the handle and the tracker could not be completely matched, so it could not be fixed with screws.There was no patient present when this issue was identified.

• Brand Name: INST 960-521 UC DRILL GUIDE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8258982
• Report Number: 1723170-2019-00318
• Device Sequence Number: 13934033
• Product Code: HAW
• UDI-Device Identifier: 00673978089904
• UDI-Public: 00673978089904
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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: Health Professional
• Device Model Number: 960-521
• Device Catalogue Number: 960-521
• Device Lot Number: 180102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1