MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR RENAISSANCE; INSTRUMENT, STEREOTAXIC

Model Number TPL0038

Device Problems Imprecision (1307); Insufficient Information (3190)

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

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a guidance system being used during a brain procedure to place leads for parkinson's disease.It was reported that the leads were placed 1 cm above the actual target during the procedure.The surgeon and manufacturer representative was unsure of the cause.There was no patient harm, and the procedure was delayed less than an hour.

Manufacturer Narrative

Analysis of the export and logs was completed.Clinical export data file was thoroughly inspected.The log file was examined with respect to all intraoperative fluoro images in order to inspect and understand procedure workflow.Fluoro images were checked and 3d registration was attempted with the registration 3d marker images utilized during the operation on a rns workstation.Analysis reviewed the planning made for the case.All planned trajectories were planned with no observable issues.According to the 3d rendering and the 3 anatomical views slices of the star marker (sm) ct scan, patient's skull had a good bone quality.In addition, insertion of each one of the rbt base screws was visually verified, and found to be inside bone, thus proper stability of rbt base was achieved.Rbt device successfully completed a 3-point setup test prior to the procedure.Sm recognition accuracy was 0.05mm ¿ within the required scope.The various fusions of the scans were repeated and visually verified.Fusions deemed accurate and good r esults were achieved by the software.After reviewing all available information, analysis ruled out issues with planning, platform stability, sm recognition and fusion.Analysis could not determine the root cause for the issue due to insufficient information.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: MAZOR RENAISSANCE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• MDR Report Key: 11008223
• MDR Text Key: 221530209
• Report Number: 3005075696-2020-00144
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K152041
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1