MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7; INSTRUMENT, STEREOTAXIC

Model Number	9733148
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system used outside of procedure.It was reported that the spine clamp was damaged.The clamp could not open and close correctly.There was no patient present.
Additional Manufacturer Narrative
The clamp, 9733148, thoracic, radiolucent was returned for analysis.Analysis found that the clamp face was slightly bent on the returned clamp.The adjustment screw had debris in the threads causing the reported difficulty opening and closing the clamp.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported that the damaged clamp was discovered in sterile processing and the cause of the damage was unknown.
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 cause was unknown.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9973841
• Report Number: 1723170-2020-01256
• Device Sequence Number: 16840268
• Product Code: HAW
• UDI-Device Identifier: 00613994201263
• UDI-Public: 00613994201263
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K990214
• 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,Followup,Followup
• Report Date (Section B): 05/05/2020

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: 9733148
• Device Catalogue Number: 9733148
• Device Lot Number: 150327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/17/2020; 04/28/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 04/28/2020; 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1