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

Model Number	960-521
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source - foreign country: (b)(6).No parts have been received by the manufacturer for evaluation.The manufacture date not known at the time of reporting.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 cervical spine procedure.It was reported that the screw thread was damaged.There was no delay to the procedure.No impact on patient outcome.
Additional Manufacturer Narrative
The drill guide was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was not confirmed.The returned drill guide was found to be in good condition with no apparent physical damage.It was able to attach to a known good tracker without issue.No problem found.Eval code method is associated with this analysis eval code result is associated with this analysis eval code conclusion is associated with this analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: S7
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8691345
• Report Number: 1723170-2019-03223
• Device Sequence Number: 13957408
• Product Code: HAW
• UDI-Device Identifier: 00673978089904
• UDI-Public: 00673978089904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 960-521
• Device Catalogue Number: 960-521
• Device Lot Number: 121011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1