MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NDI PASSIVE SPHERE

Model Number	8801075
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No procode, common device name and/or 510k provided as this device is not released for distribution in the united states.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 that pre-operatively, it was found that there was a black hair adhered in the packet seal.There was no patient associated with this event.
Additional Manufacturer Narrative
The part was returned to the manufacturer for analysis and the reported issue was confirmed.The sealed package of five had a hair sealed inside and poking outside at the edge of the package.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NDI PASSIVE SPHERE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8688748
• Report Number: 1723170-2019-03192
• Device Sequence Number: 19498866
• Product Code: HAW
• UDI-Device Identifier: 20805832070030
• UDI-Public: 20805832070030
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Expiration Date: 12/04/2020
• Device Model Number: 8801075
• Device Catalogue Number: 8801075
• Device Lot Number: 1812191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1