MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9736060
Medical Device Problem Codes	Mechanical Problem (1384); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.H4: the manufacture date is unavailable at this time.H6: no parts were returned for product analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a guidance system being used outside of a procedure.It was reported that the black tracker was having issues tracking and appeared to potentially be warped.There was no patient involvement.Additional information received indicated the tracking issue was resolved when a different tracker was used.
Additional Manufacturer Narrative
D3: correcting the manufacturing address information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; caesarea business park; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; caesarea business park; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20892854
• Report Number: 3005075696-2024-00176
• Device Sequence Number: 8710266
• Product Code: OLO
• UDI-Device Identifier: 00763000123178
• UDI-Public: 00763000123178
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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 Model Number: 9736060
• Device Catalogue Number: 9736060
• Device Lot Number: 190121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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