MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION INSTRUMENT; 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	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations.The device has not been returned to the manufacturer 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 the site had difficulty tightening the short spinous process clamp to the patient, because the screw would not tighten down.A long clamp was used instead.This issue occurred intraoperatively and did not cause any surgical delay.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
The clamp was returned to the manufacturer for analysis.Analysis found the returned clamp has difficulty closing.The threads of the adjustment screw are intact and appear to be undamaged but the screw will not thread into the base of the clamp more that a few threads before experiencing resistance.Analysis found that the reported event was related to a mechanical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION INSTRUMENT
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8687314
• Report Number: 1723170-2019-03179
• Device Sequence Number: 2220463
• Product Code: OLO
• UDI-Device Identifier: 00643169936294
• UDI-Public: 00643169936294
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131425
• 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
• Report Date (Section B): 10/09/2019

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: 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: 10/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1