MAUDE Adverse Event Report: MAZOR ROBOTICS LTD TAP SOLERA AWLTIPTAP; INSTRUMENT, STEREOTAXIC

Model Number	NAV2002
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The driver was returned for analysis.Analysis determined that the returned driver had many lines of galling on the back end causing fit issues with any mating tracker.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a guidance system and instrument being used intra-operatively of a spinal procedure.It was reported that the driver was damaged and it was unknown how it was damaged.There was no known impact on the patient outcome.Additional information was received stating that a patient was not present when this issue was discovered so there was no procedure delay.The driver was still able to verify.The damage was to the shaft of the instrument where the navlock connects to the instrument as the driver would not pass through any of the navlocks at the facility.
Additional Manufacturer Narrative
H2: after additional review it has been determined that the event did not meet reporting requirements.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: TAP SOLERA AWLTIPTAP
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67
• MDR Report Key: 9902172
• Report Number: 3005075696-2020-00081
• Device Sequence Number: 2732565
• Product Code: HAW
• UDI-Device Identifier: 00643169347540
• UDI-Public: 00643169347540
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: NAV2002
• Device Catalogue Number: NAV2002
• Device Lot Number: CA14J038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1