MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFINITY NAVIGATED OCT SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	NAV3606195
Medical Device Problem Codes	Break (1069); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: the country of the event is canada.H3.Device evaluation summary: product analysis # (b)(4): nav3606195, lot# ca19c028 visual and optical inspection confirmed the threads and the hex tip of the screwdriver have been damaged.This type of damage appears to from torsional overload.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 a patient having a spinal therapy.It was reported that the surgeon was placing a pedicle screw.During insertion the driver's thread broke, and it could no longer engage the screw.There was no patient symptom reported.There were no further complications reported regarding the event.Procedure: cervical fusion.

• Brand Name: INFINITY NAVIGATED OCT 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: 21442168
• Report Number: 1030489-2025-00878
• Device Sequence Number: 19988006
• Product Code: OLO
• UDI-Device Identifier: 00643169725461
• UDI-Public: 00643169725461
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2025

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: NAV3606195
• Device Catalogue Number: NAV3606195
• Device Lot Number: CA19C028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 02/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2019
• 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