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

Catalog Number	6000-670-000
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect Measurement (1383)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that after draping the patient for a posterior approach shunt replacement accuracy was lost.The patient had been registered in the operating position, and the tracker was positioned at the right side of the forehead with a tagaderm placed on top.It was reported that the device was registered with confirmed accuracy to sub-2mm precision.Later in the procedure, while placing the shunt stylet on the previous burr hole from the previous shunt, it was reported the device reflected the shunt was inside the brain, medial to its true location.
Additional Manufacturer Narrative
Update: h3, h6 device evaluation: follow-up report submitted to document the device evaluation.Update: b5 additional information: follow-up report submitted to further clarify outcome of procedure and patient condition.
Event or Problem Description
The customer reported that after draping the patient for a posterior approach shunt replacement accuracy was lost.The patient had been registered in the operating position, and the tracker was positioned at the right side of the forehead with a tagaderm placed on top.It was reported that the device was registered with confirmed accuracy to sub-2mm precision.Later in the procedure, while placing the shunt stylet on the previous burr hole from the previous shunt, it was reported the device reflected the shunt was inside the brain, medial to its true location.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.

• Brand Name: CRANIAL GUIDANCE 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: 17930834
• Report Number: 3015967359-2023-02105
• Device Sequence Number: 6350813
• Product Code: HAW
• UDI-Device Identifier: 07613327538298
• UDI-Public: 07613327538298
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 6000-670-000
• Device Lot Number: VERSION: 4.0-28/028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 03/05/2024
• 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