MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST 960-553 PLANAR PASSIVE SHARP PROBE; INSTRUMENT, STEREOTAXIC

Model Number	960-553
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
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.It was reported that during a sacroiliac and thoracolumbar procedure that the spheres were not being tracked when five passive markers were attached to the passive probe.The issue was not resolved even though the passive markers were replaced with new ones.The procedure was completed by replacing the passive probe with ball chip probe.There was a delay to the procedure of less than one hour.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that the instrument was damaged.It was noted that the passive planar probe was deformed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that the damage was caused by cleaning and normal use.
Additional Manufacturer Narrative
The instrument was returned to the manufacturer for analysis.Through functional testing and visual/physical examination the reported issue could not be confirmed.The returned probe was found to be in good condition with no apparent physical damage.With markers attached and fully seated, the probe returned good geometry and divot error readings with normal tracking.No problem found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INST 960-553 PLANAR PASSIVE SHARP PROBE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9118771
• Report Number: 1723170-2019-05007
• Device Sequence Number: 14107213
• Product Code: HAW
• UDI-Device Identifier: 00673978090108
• UDI-Public: 00673978090108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972398
• 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,Followup,Followup
• Report Date (Section B): 11/25/2019

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: 960-553
• Device Catalogue Number: 960-553
• Device Lot Number: 160614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/07/2019; 10/28/2019; 11/18/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/25/2019; 11/14/2019; 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1