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	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device indicated that the device wouldn't wouldn't fully mate with each other.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 was 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 navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported the drill bit does not fit easily into the blue tracker.It was noted marring could be seen on the shaft of the bit.This issue occurred intraoperatively and caused a less than one-hour surgical delay.There was no reported impact on patient outcome.Additional information received from a manufacturer representative reported the drill bit and tracker were locked up.The manufacturer representative was not able to determine how locked up the devices were since they were still in the sterile field.Additional information received from a manufacturer representative reported that the surgeon was using the blue tracker with the a drill and the bit started binding up on the tracker which caused the tracker to not spin freely.The instruments were removed from the patient and a mallet was used to separate the bit from the tracker.

• 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: 8480431
• Report Number: 1723170-2019-01527
• Device Sequence Number: 11171106
• 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
• Patient Age: 69 YR
• Patient Weight: 90