MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X STEALTH EDITION SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problems Imprecision (1307); Output Problem (3005)

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

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: pn: asm0206-01r, sn/ln: unk.A manufacturer representative went to the site to test the guidance system.It was found that one of the arm guides was bent thus causing the accuracy pointer to rub against the inner edge of the hole resulting in a failed test.If information is provided in the future, a supplemental report will be issued.

Event Description

2medtronic received information regarding a guidance system being used during a spinal procedure.It was reported that while sending the surgical arm to a trajectory, the trajectory was superior by 1.5 mm.A surgical arm accuracy check was done in the divot on the system and the anatomy and navigation was accurate.When sending the surgical arm back to the trajectory, the surgeon said they were fighting the arm to get it in the correct trajectory.The cause of the trajectory being off was not determined.An accuracy test was completed after the case and the accuracy pointer was hitting the rim of the divot and then sliding into the divot on the arm.The surgical arm failed the advanced accuracy test.There was no patient harm and the procedure was delayed less than an hour.Additional information was received stating that we were using the guidance system to place screws.The screws were showing as superior on navigation, and felt this way to the surgeon during operation.He used counterpressure to place screws and ultimately, they proved to be accurate.The case was completed successfully.

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: pn: asm0206-01r, serial number: (b)(6).Analysis of the surgical arm found the complaint was confirmed.Visual/physical examination and functional testing found the surgical arm failed an accuracy and stress test.The j1 body failed, the j3 and j6 motors were faulty, the j6 driver failed, the j6 plastic gear and motor gear were faulty and the camera was the old version.The surgical arm was repaired, recalibrated and passed all testing.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 X STEALTH EDITION SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• MDR Report Key: 10880203
• MDR Text Key: 228436413
• Report Number: 3005075696-2020-00127
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109183213
• UDI-Public: 07290109183213
• Combination Product (y/n): N
• PMA/PMN Number: K182077
• 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: 03/01/2021

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: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1