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

Model Number	9734715
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.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.It was reported outside of a procedure that when the teeth of the clamp are fully opened, the closing screw was not catching the teeth so the site needs to hold the teeth between their fingers in order to start turning the screw to catch and close the clamp teeth, the site evaluated another clamp and it was working differently.No patient was present at the time of the event.

• Brand Name: S7
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8290024
• Report Number: 1723170-2019-00458
• Device Sequence Number: 1953328
• Product Code: OLO
• UDI-Device Identifier: 00643169936300
• UDI-Public: 00643169936300
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131425
• 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
• Report Date (Section B): 01/30/2019

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: No Information
• Device Model Number: 9734715
• Device Catalogue Number: 9734715
• Device Lot Number: 180119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1