MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEMAP® 3D 3.1 - SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6002-680-000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, during a posterior lumbar fusion using nav3i and ziehm, the surgeon complained of inaccuracy.After conducting the first spin (0.33mm automatic registration deviation) and completing the right side with kwires the surgeon moved to the left side, and complained that "accuracy was off." the customer attributed the ngenius tracker (on orthopins) as potentially being "bumped." a second spin (0.50mm deviation) was conducted and 6 screws were placed in the patient.The surgeon was still unsure of accuracy, so three staples were placed in the patients back within the scan center and a third spin was conducted (0.43mm deviation).After conducting the spin and removing the z-drape, accuracy was checked with the long pointer down the center of one of the screw tulips and touching on the staples, there still appeared to be inaccuracy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Correction: follow-up report submitted to document the device was not available for evaluation.H3 other text : log files not submitted by customer for evaluation.
Event or Problem Description
Per the customer, during a posterior lumbar fusion using nav3i and ziehm, the surgeon complained of inaccuracy.After conducting the first spin (0.33mm automatic registration deviation) and completing the right side with kwires the surgeon moved to the left side, and complained that "accuracy was off." the customer attributed the ngenius tracker (on orthopins) as potentially being "bumped." a second spin (0.50mm deviation) was conducted and 6 screws were placed in the patient.The surgeon was still unsure of accuracy, so three staples were placed in the patients back within the scan center and a third spin was conducted (0.43mm deviation).After conducting the spin and removing the z-drape, accuracy was checked with the long pointer down the center of one of the screw tulips and touching on the staples, there still appeared to be inaccuracy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: SPINEMAP® 3D 3.1 - 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: 16589495
• Report Number: 3015967359-2023-00591
• Device Sequence Number: 14161771
• Product Code: HAW
• UDI-Device Identifier: 07613327359954
• UDI-Public: 07613327359954
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/25/2023

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: 6002-680-000
• Device Catalogue Number: 6002-680-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 07/25/2023
• 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: Unknown