MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER NAV3I(TM) PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	7700-800-000
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility during an anatomical registration the customer was unable to achieve accurate registration of the patient landmarks and was unable to proceed with using the device for the procedure.The landmarks ensure accuracy of the device during the procedure.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 prior to a surgical procedure at the user facility during an anatomical registration the customer was unable to achieve accurate registration of the patient landmarks and was unable to proceed with using the device for the procedure.The landmarks ensure accuracy of the device during the procedure.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Additional information added for d4, d10, h3, h4 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10233695
• Report Number: 0001811755-2020-01637
• Device Sequence Number: 3093076
• Product Code: HAW
• UDI-Device Identifier: 07613327004175
• UDI-Public: 07613327004175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 06/09/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1