MAUDE Adverse Event Report: MEDTRONIC NAVIGATION INC INST KIT 9734913 PROBE THORACIC ASSY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734913
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involved.No devices were returned to the manufacturer for analysis.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system used outside of procedure.It was reported that a thoracic probe tip is bent.No patient present at the time of event.
Event or Problem Description
Additional information was received stating the probe could not be verified because it was bent.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3) the probe was returned to the manufacturer for analysis.Visual / physical examination confirmed the reported issue.The tip of t he returned probe was twisted.There were also lines of galling on the back end causing fit issues with any mating tracker.This issue has been documented in the hardware anomaly tracking database.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.

• Brand Name: INST KIT 9734913 PROBE THORACIC ASSY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9581212
• Report Number: 1723170-2020-00123
• Device Sequence Number: 3012264
• Product Code: OLO
• UDI-Device Identifier: 00763000207625
• UDI-Public: 00763000207625
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2020

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: No Information
• Device Model Number: 9734913
• Device Catalogue Number: 9734913
• Device Lot Number: 190116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 04/25/2020; 08/13/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/27/2020; 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1