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

Model Number NAV3606195

Device Problems Mechanical Jam (2983); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via field representative regarding patient with unknown indication involved in c2-t2 fusion procedure.It was reported that during procedure, when infinity posterior cervical system navigated threaded driver was being used with navlock tracker, the driver became stuck with the tracker and would not rotate.The driver and tracker had to be separated forcefully.The shaft of the driver has scoring where it connects with the navlock and would not insert fully or rotate with the tracker.There was no delay in overall procedure time.There were no patient symptoms or complications reported as a result of this event.Patient is alive and no injury.

Manufacturer Narrative

H3: device evaluated summary- it appears that the nav tap may have bent/flexed during use causing it to bind in the tracker.There are wear marks on the back side of the tap from rubbing but the diameter at this location appears to be worn from repeated use.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFINITY NAVIGATED OCT SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11991688
• MDR Text Key: 255978777
• Report Number: 1030489-2021-00787
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K173338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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 Operator: Health Professional
• Device Model Number: NAV3606195
• Device Catalogue Number: NAV3606195
• Device Lot Number: CA18A001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 10/23/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1