MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PROBE 9733457 PEDICLE 2.25MM; INSTRUMENT, STEREOTAXIC

Model Number	9733457
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that the 2.25 pedicle probe was damaged.There was no patient present at the time of the event.
Additional Manufacturer Narrative
The pedicle probe was returned to the manufacturer for analysis.After visual examination, it was noted that the tip of the returned probe is severely bent.The hardware investigation found that the reported event was related to a hardware issue.Codes are related to the hardware analysis.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a manufacturer representative indicated the issue was discovered prior to a procedure by the clinical specialist.It was clarified the pedicle probe was bent coming out of the tray.The probe was not used for the procedure.

• Brand Name: PROBE 9733457 PEDICLE 2.25MM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9535917
• Report Number: 1723170-2019-06231
• Device Sequence Number: 14072006
• Product Code: HAW
• UDI-Device Identifier: 00613994335968
• UDI-Public: 00613994335968
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2020

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: Health Professional
• Device Model Number: 9733457
• Device Catalogue Number: 9733457
• Device Lot Number: 140403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/02/2020; 03/26/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/08/2020; 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1