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

Model Number	NAV3606030
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis # (b)(4): product: nav3606030, lot: ca19c024.Visual and microscopic examination confirmed that the tip of the tap has broken due to overload.Radiographic image review results: lateral x-ray a screw is present on one side of c2, described fractured instrument appears on the other side.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 tap used on patient having c2-t2 cervical myelopathy therapy.It was reported that the tip of the tap broke off inside the bone and the tip was left in the patient.The case was completed by using a 3.0 tap.The tip could not be retrieved and had to stay in the patient, but it is in c2 on the right side.This was a brand new 2.4 drill bit out of the box and had been used for maybe 20 minutes prior to this happening.There was no patient symptoms reported as a result of this event.There were no further complications reported regarding the event.

• 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: 23533406
• Report Number: 3003120897-2025-00555
• Device Sequence Number: 9140943
• Product Code: OLO
• UDI-Device Identifier: 00643169725423
• UDI-Public: (01)00643169725423(11)190903(10)CA19C024
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: NAV3606030
• Device Catalogue Number: NAV3606030
• Device Lot Number: CA19C024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2019
• 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 Age: 38 YR
• Patient Sex: Female