MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734683

Device Problem Imprecision (1307)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used during a spinal procedure.It was reported that when placing the screw the screw was not on bone on the projection when the surgeon's tactile feel was telling him he was on bone.They switched screwdrivers and then were unable to register.It was not clear if the screwdrivers were bent or if the tracker's geometry was off or if there were other factors that caused the issue.There was no reported delay and no reported impact to patient outcome.Additional information was received stating that the health care professional was claiming that the screwdriver was a couple of mm off on navigation when he was touching bone.The instrument would not reverify, which furthered the doubt that something was off with the screwdriver.The screwdriver was replaced.The inaccuracy occurred while actively operating on the patient.The issue was determined to most likely be due to the screwdriver since it could not re-register.

• Brand Name: NAVLOCK
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13397828
• MDR Text Key: 288791674
• Report Number: 1723170-2022-00131
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2022

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: 9734683
• Device Catalogue Number: 9734683
• Device Lot Number: 190806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male