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.

• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• 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
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

0 Patients were 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

• Device Model Number: 7700-800-000
• Device Catalogue Number: 7700-800-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse