MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC SURETRAK¿ II UNIVERSAL TRACKER, LARGE PASSIVE FIGHTER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	961-581
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Problem (1384); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6) the product: 961-581, lot number: 150728, returned to the manufacturer and analysis confirmed the reported event.The returned instrument was severely bent and the tracker was not usable as it was.Codes b01, c07, c13, and d02 are applicable to this returned product analysis.A1-5: select patient information cannot be provided due to regional privacy regulations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a sacroiliac and thoracolumbar procedure.It was reported that when the user tried to remove it from the instrument, the screw portion broke and was difficult to remove.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.
Additional Manufacturer Narrative
H2) additional information in section b5.H2) due to additional information provided, annex a has been updated from a040103 to a05.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information clarified the initial allegation.It was reported that the tip of the tap was "lacked" and there was recognition failure with the tracker.
Additional Manufacturer Narrative
H2) correction made to annex a code.Annex a has been corrected from a05 to a0709.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SURETRAK¿ II UNIVERSAL TRACKER, LARGE PASSIVE FIGHTER
• Common Device Name: 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19373829
• Report Number: 1723170-2024-01335
• Device Sequence Number: 20755311
• Product Code: OLO
• UDI-Device Identifier: 00721902467684
• UDI-Public: 00721902467684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2024

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: 961-581
• Device Catalogue Number: 961-581
• Device Lot Number: 150728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 07/19/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/19/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown