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

Model Number	9734734
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the tracker, lot number: 210111, was returned to the manufacturer for analysis.The returned tracker showed signs of galling inside toward the latch that prevented the insertion of a known good instrument into the tracker.The reported event could be duplicated by medtronic personnel.Codes b01, c07, and d02 are applicable to this analysis.H6: a05 - instrument issues a0506 - tracker could not rotate 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 navigation system being used during a cervical spine procedure.It was reported that the tracker could not be connected to the spinal tap driver.Even if the connection was made, the device was interfering and the tracker could not rotate.It was reported that before inserting the 5th screw, and attempt was made to create a pilot hole using the tap and the tracker, but the bone was too hard, and progress could not be made.Upon inspection outside of the surgical field, it was found that the tap and tracker were stuck together, there were no problems up to the 4th screw.After surgery, the adhesion was released, and an attempt was made to insert each into other taps and trackers.However, assembly was not possible for both.There was no impact to patient's outcome and surgical delay was less than one-hour.Additional information was received.The navigation and imaging system were used as troubleshooting.Additional information was received.It was reported that the surgery continued with a different naval block.

• Brand Name: NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23598149
• Report Number: 1723170-2025-03775
• Device Sequence Number: 16030862
• Product Code: OLO
• UDI-Device Identifier: 00763000054489
• UDI-Public: (01)00763000054489(11)210111(10)210111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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: 9734734
• Device Catalogue Number: 9734734
• Device Lot Number: 210111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• 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