MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STRYKER NAV3I(TM) PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	7700-800-000
Medical Device Problem Codes	Device Handling Problem (3265); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility navigation equipment was unable to be registered and its use was canceled.The device had another patient's anatomy loaded which could cause an inaccuracy.The procedure was completed successfully without a clinically significant delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during a procedure at the user facility navigation equipment was unable to be registered and its use was canceled.The device had another patient's anatomy loaded which could cause an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6.Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: STRYKER NAV3I(TM) PLATFORM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11738756
• Report Number: 3015967359-2021-00728
• Device Sequence Number: 11868913
• Product Code: HAW
• UDI-Device Identifier: 07613327004175
• UDI-Public: 07613327004175
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 7700-800-000
• Device Catalogue Number: 7700-800-000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1