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	Incorrect Measurement (1383); Intermittent Program or Algorithm Execution (4035)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, after re-spinning the ziehm c-arm due to the surgical staff bumping the patient tracker during the case and causing accuracy problems, the local correlation for the preoperative l1 vertebrae from ct1 was unable to be merged with ct3.The q-guidance software would not allow ct1 to be merged with ct3 at this level, only allowing ct1 to be merged with the previous ct2.The q guidance software would allow merging of other local correlations to the new scan.Per the clinical specialist the procedure was aborted following other problems in the operating room.The procedure was completed successfully two days later with a different device.
Event or Problem Description
Per the customer, after re-spinning the ziehm c-arm due to the surgical staff bumping the patient tracker during the case and causing accuracy problems, the local correlation for the preoperative l1 vertebrae from ct1 was unable to be merged with ct3.The q-guidance software would not allow ct1 to be merged with ct3 at this level, only allowing ct1 to be merged with the previous ct2.The q guidance software would allow merging of other local correlations to the new scan.Per the clinical specialist the procedure was aborted following other problems in the operating room.The procedure was completed successfully two days later with a different device.
Additional Manufacturer Narrative
Update: d9, h3, h6 correction: follow-up report submitted to document the device was not available for evaluation.Not all log files were submitted by the customer for evaluation.

• 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: 16294696
• Report Number: 3015967359-2023-00358
• Device Sequence Number: 7518284
• Product Code: HAW
• UDI-Device Identifier: 07613327503265
• UDI-Public: 07613327503265
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/23/2023

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: 01/09/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 05/23/2023
• 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