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	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, while performing mis fusion case the nav locked gear shift was inaccurate.The device showed that the instrument was directly down the pedicle, however fluoro showed the instrument lateral with no part of it in bone.After recalibrating, the instruments accuracy was better but soon lost accuracy after being progressed down the pedicle.Within the same screw hole, the surgeon would rotate the instrument and depending on which side the tracker was moved, it would show the instrument in two completely different locations (both of which were inaccurate).The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
Per the customer, while performing mis fusion case the nav locked gear shift was inaccurate.The device showed that the instrument was directly down the pedicle, however fluoro showed the instrument lateral with no part of it in bone.After recalibrating, the instruments accuracy was better but soon lost accuracy after being progressed down the pedicle.Within the same screw hole, the surgeon would rotate the instrument and depending on which side the tracker was moved, it would show the instrument in two completely different locations (both of which were inaccurate).The procedure was completed successfully without a clinically significant 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: 17079234
• Report Number: 3015967359-2023-01238
• Device Sequence Number: 17703248
• Product Code: HAW
• UDI-Device Identifier: 07613327359954
• UDI-Public: 07613327359954
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K002732
• 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): 07/19/2023

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: 6002-680-000
• Device Catalogue Number: 6002-680-000
• Device Lot Number: VERSION: 3.1-19/019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/19/2023
• 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