MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CANNULA 2.5 DIAMETER; INSTRUMENT, STEREOTAXIC

Model Number	963-776
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is unavailable.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 for a procedure.It was reported that during the cleaning after the procedure, it was noted that the guide wire could not be removed from the drill guide and the site was requesting repair.The procedure had been completed and there was no reported impact to the patient outcome.There was no reported surgical delay due to this issue.
Additional Manufacturer Narrative
Additional information: the cannula was returned to the manufacturer for analysis.Analysis found that an unknown tool, not a guide wire, had been inserted into the cannula and was now stuck.The diameter of the unknown tool was nearly the same as the cannula.It was not possible to separate the two pieces.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that the procedure type was a cervical laminoplasty.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that the procedure was a cervical case, but it was unknown whether it was a laminoplasty.

• Brand Name: CANNULA 2.5 DIAMETER
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8471968
• Report Number: 1723170-2019-01484
• Device Sequence Number: 1664104
• Product Code: HAW
• UDI-Device Identifier: 00673978963358
• UDI-Public: 00673978963358
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2019

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: 963-776
• Device Catalogue Number: 963-776
• Device Lot Number: 120621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 05/09/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/08/2019; 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1