MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAIN CART 9735666 STEALTH S8 BASIC; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734716
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the surgeon could not adjust the screw in the clamp to open and it was preventing the clamp from being used.The representative noted the screw top looked jammed.The site used a different clamp to proceed with the procedure.There was no reported delay and no reported impact to patient outcome.
Additional Manufacturer Narrative
The clamp was returned to the manufacturer for analysis.Analysis found that the clamp was intact and fully functional per design.No problem was found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAIN CART 9735666 STEALTH S8 BASIC
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9220850
• Report Number: 1723170-2019-05319
• Device Sequence Number: 14166196
• Product Code: OLO
• UDI-Device Identifier: 00643169936294
• UDI-Public: 00643169936294
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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 Model Number: 9734716
• Device Catalogue Number: 9734716
• Device Lot Number: 180118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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: 80