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	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pedicle probe was returned to the manufacturer for analysis.The tip of the returned probe is slightly bent.With markers attached and fully seated, the probe displays a good geometry error but a high divot error due to the bent tip.The hardware investigation found that the reported event was related to a hardware issue.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 in a cervical spine.It was reported that it was difficult to register the cervical probe because it had a deformed tip.The cervical probe was used while checking the position with a normal pointer.There was no reported delay to the case.No impact on patient outcome.On 2020-feb-24, it was reported that the probe could still pass verification.

• 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: 9849822
• Report Number: 1723170-2020-00954
• Device Sequence Number: 765244
• 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
• Report Date (Section B): 03/18/2020

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: 150807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1