MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK UNIV BLUE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9736061
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned navlock indicated there was visible galling on the receiving bore of the tracker that aligns with the damage on the drill bit.When a known good instrument in inserted into the tracker, there was now a slight resistance when inserting into the tracker.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a guidance system being used during a spinal procedure to treat a deformity.It was reported that the drill bit did not fit easily into the blue tracker, the drill bit started to bind and was not spin freely with the blue tracker when drilling through the arm guide, and there was marring on the shaft of the drill bit.The drill and the bit with the tracker was removed from the patient and then manually separated using a mallet.The drill bit was able to be used with the black tracker, but there was more friction between the drill bit and track than normal.The tracker was tried with other drill bits and the issue did not occur.The manufacturer representative thought there was some damage/marring on the inside of the cannula of the tracker, but not enough to affect other instruments.The manufacturer representative also stated that if the drill was not completely coaxial while drilling, the tracker would bind up.Screws were being implanted at c4 to t12 and the devices were prepared according to labeling.There was no patient harm, no delay in the procedure for more than an hour and no additional actions were required as a result of the event.

• Brand Name: NAVLOCK UNIV BLUE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8480100
• Report Number: 1723170-2019-01525
• Device Sequence Number: 16551448
• Product Code: OLO
• UDI-Device Identifier: 00763000123185
• UDI-Public: 00763000123185
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• 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
• Report Date (Section B): 04/03/2019

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: 9736061
• Device Catalogue Number: 9736061
• Device Lot Number: 180921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1