MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 2.25 MM PEDICLE PROBE; INSTRUMENT, STEREOTAXIC

Model Number	9733457
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation instrument outside of procedure.It was reported that the probe had a deformed tip.During the regular inspection, the cervical probe could be verified, but it was visually confirmed that the probe was bent.Slight inaccuracy was also confirmed in the bone model.There was no patient present.
Additional Manufacturer Narrative
The probe was returned for analysis.Through visual and functional testing it was determined that the probe had no apparent physical damage.With markers attached and fully seated, the probe returned good geometry and divot error readings.No problem was found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 2.25 MM PEDICLE PROBE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8508900
• Report Number: 1723170-2019-01703
• Device Sequence Number: 11178568
• Product Code: HAW
• UDI-Device Identifier: 00613994335968
• UDI-Public: 00613994335968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 9733457
• Device Catalogue Number: 9733457
• Device Lot Number: 150911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2019
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1