MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7; INSTRUMENT, STEREOTAXIC

Model Number	9733066
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a cranial resection.It was reported that the screw broke when using the base.The health care professional retrieved the broken part from the patient.There was less than an hour delay in the procedure.No impact on patient outcome.
Additional Manufacturer Narrative
A manufacturer representative went to the site to test the navigation system.A system checkout was performed and the system is working as intended.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a cranial resection.It was reported that the screw broke when using the base.The health care professional retrieved the broken part from the patient.There was less than an hour delay in the procedure.No impact on patient outcome.
Additional Manufacturer Narrative
The trajectory guide was returned to the manufacturer for evaluation.After visual/physical examination the reported issue was confirmed.One of the three screws had broken off.The broken piece was included in the return.Physical damage was observed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a cranial resection.It was reported that the screw broke when using the base.The health care professional retrieved the broken part from the patient.There was less than an hour delay in the procedure.No impact on patient outcome.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8236481
• Report Number: 1723170-2019-00201
• Device Sequence Number: 1745920
• Product Code: HAW
• UDI-Device Identifier: 00643169702929
• UDI-Public: 00643169702929
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2019

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: 9733066
• Device Catalogue Number: 9733066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 01/18/2019; 03/05/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/06/2019; 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 75