MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734683
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The navlock was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.One of the two side tabs of the returned tracker has been broken off at the tip.Otherwise, with markers attached and fully seated, the returned tracker displayed good geometry and divot error readings with normal tracking and verification.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the orange instrument tracker was defective.There was no patient present when this issue was identified.

• Brand Name: NAVLOCK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 11140351
• Report Number: 1723170-2021-00057
• Device Sequence Number: 16312935
• Product Code: OLO
• UDI-Device Identifier: 00763000076634
• UDI-Public: 00763000076634
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: 9734683
• Device Catalogue Number: 9734683
• Device Lot Number: 191007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1