MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG STRYKER NAV3I(TM) PLATFORM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	7700-800-000
Medical Device Problem Codes	Imprecision (1307); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, automatic registration not accurate on nav3i with ziehm c arm.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Event or Problem Description
Per the customer, automatic registration not accurate on nav3i with ziehm c arm.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: STRYKER NAV3I(TM) PLATFORM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg MI D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18256406
• Report Number: 3015967359-2023-02539
• Device Sequence Number: 17813782
• Product Code: HAW
• UDI-Device Identifier: 07613327004175
• UDI-Public: 07613327004175
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• 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): 09/24/2024

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: Health Professional
• Device Catalogue Number: 7700-800-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown