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

Model Number	8801075
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 510k was not available at the time of reporting.No parts have been received by the manufacturer for evaluation.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 sacroiliac and thoracolumbar procedure.It was reported that when the site was doing a final count to their instruments used during a procedure, they discovered that one of the spheres was damaged and split in half.The other half of the sphere was located on the surgical drape.The sphere was discarded and is not available to be sent in.There was no delay to the procedure.No impact on patient outcome.Additional information received stating that the damage to the spheres did not occur inside of the patient anatomy.

• Brand Name: SPHERE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9383739
• Report Number: 1723170-2019-05806
• Device Sequence Number: 19461527
• Product Code: HAW
• UDI-Device Identifier: 20805832070030
• UDI-Public: 20805832070030
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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: No Information
• Device Expiration Date: 06/27/2021
• Device Model Number: 8801075
• Device Catalogue Number: 8801075
• Device Lot Number: 1908221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 32