MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC RIALTO¿ SI FUSION SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAV7426001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: part # nav7426001, lot # ca21j102 visual and optical inspection confirmed the instrument has a small section of displaced material/galling on the o.D.Of the shaft.Functional check with a sample nav tracker confirmed the drill bit was able to attach but bind when spun in the tracker.It appears that the material is displaced, and the areas of positive displacement are causing the attachments to get hung on the instrument¿s shaft.The damage appears to have been caused by the bending of the driver when under a load when attached and spinning in the tracker.This regulatory report is being submitted due to retrospective review through capa 624392.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
Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event which occurred during a si fusion procedure.It was reported that the instruments broke.The instruments got stuck in the navigated nav locks.They would not spin while using the powerease.They also had indentions on the shafts.Instruments came in contact with the patient. there was no patient symptom reported.There were no further complications reported regarding the event.

• Brand Name: RIALTO¿ SI FUSION SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21442894
• Report Number: 1030489-2025-00926
• Device Sequence Number: 7196563
• Product Code: OLO
• UDI-Device Identifier: 00643169571808
• UDI-Public: 00643169571808
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K161210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: NAV7426001
• Device Catalogue Number: NAV7426001
• Device Lot Number: CA21J102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 02/23/2025
• 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: Female