MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PASSIVE PLANAR BALL 1.5MM; INSTRUMENT, STEREOTAXIC

Model Number	960-559
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported that the passive ball point tip was damaged.This was found in the sterile processing department (spd).There was no patient present when this issue was identified.
Additional Manufacturer Narrative
Initial reporter updated.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 probe had come down to the sterile processing department from the or and it was marked as bent.The site had initiated ordering a replacement probe and it was noted that the root cause was not explained to the sterile processing department and was also unknown by the or neuro coordinator.The probe was bent so it would not properly register.It was noted that the probe could not be registered when tested by a manufacturing representative (rep) and that the tip was too far from divot.The probe would not verify so it was marked for repair.

• Brand Name: PASSIVE PLANAR BALL 1.5MM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8977078
• Report Number: 1723170-2019-04809
• Device Sequence Number: 311296
• Product Code: HAW
• UDI-Device Identifier: 00673978090153
• UDI-Public: 00673978090153
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K972398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: 960-559
• Device Catalogue Number: 960-559
• Device Lot Number: 170213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1