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

Model Number 7700-800-000

Device Problems Device Handling Problem (3265); Intermittent Communication Failure (4038)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Event 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 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.

Manufacturer Narrative

Update: d9, h3, h6.Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: STRYKER NAV3I(TM) PLATFORM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11738756
• MDR Text Key: 248780642
• Report Number: 3015967359-2021-00728
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07613327004175
• UDI-Public: 07613327004175
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7700-800-000
• Device Catalogue Number: 7700-800-000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1