MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CRANIALMAP SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-660-000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer during a navigated cranial case with the nav3i, the surgeon felt the system was showing the instrument at a different depth than where he felt he was.The surgeon continued with the case and wanted to wait until after the case to troubleshoot.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Event or Problem Description
Per the customer during a navigated cranial case with the nav3i, the surgeon felt the system was showing the instrument at a different depth than where he felt he was.The surgeon continued with the case and wanted to wait until after the case to troubleshoot.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.

• Brand Name: CRANIALMAP SOFTWARE
• 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: 17377579
• Report Number: 3015967359-2023-01484
• Device Sequence Number: 12358414
• Product Code: HAW
• UDI-Device Identifier: 07613327327199
• UDI-Public: 07613327327199
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/27/2023

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 Catalogue Number: 6000-660-000
• Device Lot Number: VERSION: 3.0-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 11/26/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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