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

Catalog Number	6000-660-000
Medical Device Problem Codes	Imprecision (1307); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, there was an "intraop navigation inaccuracy," issue with the device.The navigation device showed different location in axial, coronal and sagittal views, with respect to patient anatomy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6 correction: follow-up report submitted to document the device log files were not available for evaluation.H3 other text : log files not submitted by customer for evaluation.
Event or Problem Description
Per the customer, there was an "intraop navigation inaccuracy," issue with the device.The navigation device showed different location in axial, coronal and sagittal views, with respect to patient anatomy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• 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: 17871045
• Report Number: 3015967359-2023-02064
• Device Sequence Number: 18014830
• Product Code: HAW
• UDI-Device Identifier: 07613327327199
• UDI-Public: 07613327327199
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K162929
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• Device Catalogue Number: 6000-660-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 03/05/2024
• 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: Unknown