MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STRYKER Q GUIDANCE SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	8900-100-000
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Incorrect Measurement (1383); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, auto-segmentation was not available after the airo scan as the licensing for it was not implemented.While navigating screws, there appeared to be movement on the screen/images without anything touching the screen.After a confirmation spin with the airo, 2 out of 8 screws were angled more cranial despite following our preplanned trajectory.The two screws were revised after the confirmation scan.The procedure was completed successfully with the same device without a clinically significant delay; no medical intervention or adverse consequences were reported.
Event or Problem Description
Per the customer, auto-segmentation was not available after the airo scan as the licensing for it was not implemented.While navigating screws, there appeared to be movement on the screen/images without anything touching the screen.After a confirmation spin with the airo, 2 out of 8 screws were angled more cranial despite following our preplanned trajectory.The two screws were revised after the confirmation scan.The procedure was completed successfully with the same device without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Follow-up report submitted to document the device was not available for evaluation.No product return.

• Brand Name: STRYKER Q GUIDANCE SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16444838
• Report Number: 3015967359-2023-00487
• Device Sequence Number: 14835360
• Product Code: HAW
• UDI-Device Identifier: 07613327503265
• UDI-Public: 07613327503265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K220593
• 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): 06/19/2023

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
• Device Model Number: 8900-100-000
• Device Catalogue Number: 8900-100-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male