MAUDE Adverse Event Report: STRYKER SPINE-US SHUNT PLACEMENT TOOL L 2-4; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-074-000
Medical Device Problem Codes	Imprecision (1307); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the accuracy of a shunt placement tool was "off" during a case.The procedure was completed successfully without a surgical delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem Description
It was reported that the accuracy of a shunt placement tool was "off" during a case.The procedure was completed successfully without a surgical delay; no adverse consequences or medical intervention were reported.

• Brand Name: SHUNT PLACEMENT TOOL L 2-4
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18544810
• Report Number: 0008010177-2024-00007
• Device Sequence Number: 7780259
• Product Code: HAW
• UDI-Device Identifier: 04546540469991
• UDI-Public: 04546540469991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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: 6000-074-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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