MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST 960-539 GUIDE BIOPSY; INSTRUMENT, STEREOTAXIC

Model Number	960-539
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned to the manufacturer for analysis.Device manufacturing date is unavailable.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 during an unknown procedure.It was reported that during a clinical case the site was having issues with the pad as it was noted the second wingnut on the device was to hard to turn and tighten.The site had to use a large amount of force until it was able to be used.The clinical specialist is requesting a quote for replacement.Patient was present.There was a less than 5 min delay noted in the case.New information received: the type of surgical procedure is cranial biopsy.
Additional Manufacturer Narrative
Analysis on the returned biopsy guide resulted in a mechanical damage failure that was found.Analysis states that the lower joint is difficult to lock down.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INST 960-539 GUIDE BIOPSY
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9940719
• Report Number: 1723170-2020-01187
• Device Sequence Number: 16337885
• Product Code: HAW
• UDI-Device Identifier: 00681490991520
• UDI-Public: 00681490991520
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K954276
• 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): 05/08/2020

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: 960-539
• Device Catalogue Number: 960-539
• Device Lot Number: 111111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 77