MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC REGISTRATION PROBE; INSTRUMENT, STEREOTAXIC

Model Number	9733446
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the 9733446 found a damaged tool.As reported, one of the two latch pins had been pushed into the body of the probe.As a result, the mating tracker was not secure when it attached to the probe and could easily be pulled off.The probe was otherwise in good condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system while in a functional endoscopic sinus surgery (fess) procedure.It was reported that the piece that holds the instrument tracker seems to be pushed in or broken.Surgeon noticed that the instrument tracker was not staying on the registration probe when registering patient.The procedure was completed with the use of navigation.There was a delay of less than 1 hour.No known impact on patient outcome.

• Brand Name: REGISTRATION PROBE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8628411
• Report Number: 1723170-2019-02514
• Device Sequence Number: 16696157
• Product Code: HAW
• UDI-Device Identifier: 00613994378538
• UDI-Public: 00613994378538
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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: 9733446
• Device Catalogue Number: 9733446
• Device Lot Number: 11602A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1