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

Model Number	9735023
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: foreign country - canada.H3/h6: the analysis was completed.The reported problem was confirmed.The tip of the returned driver had been broken off.Codes b01, c07, and d02 apply.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.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that the instrument head was stripped, therefore the screw was unable to be placed with navigation.The health care professional reverted to using a non-navigated driver instrument instead.There was a delay of 5 -10 minutes.No reported impact on patient.

• Brand Name: SOLERA DRIVER
• 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 ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22729288
• Report Number: 1723170-2025-02918
• Device Sequence Number: 8418896
• Product Code: OLO
• UDI-Device Identifier: 00643169545809
• UDI-Public: (01)00643169545809(11)161113(10)CA16G056
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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: 9735023
• Device Catalogue Number: 9735023
• Device Lot Number: CA16G056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/06/2025
• 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