MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PERCUTANEOUS REFERENCE CROSS PIN FRAME; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	9732353
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable.No parts have been 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 device being used for a sacroiliac and thoracolumbar procedure.It was reported that the percutaneous pin would not fit into the percutaneous reference frame.The end user tried sterile mineral oil to lubricate the post but had no success.A second percutaneous pin was tried without success.The pin was wedged into the post of the percutaneous frame; no movement of pin to frame was seen and the surgeon moved forward with the procedure.Navigation was not discontinued, and medtronic imaging was used and completed without incident.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.It was suspected there was damage to the reference frame when two percutaneous pins of different lots would not fit.The site ordered and received a new frame at a later date.At this time a medtronic representative (rep) tried the percutaneous pins saved from the incident.The same issue occurred with both percutaneous pins.Upon advice from technical services (ts), a new percutaneous pin was opened from the shelf and it would successfully fit into the new frame but not the old frame.It was not until the frame was replaced that errant percutaneous pin diameter was suspected.

• Brand Name: PERCUTANEOUS REFERENCE CROSS PIN FRAME
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8406316
• Report Number: 1723170-2019-01025
• Device Sequence Number: 389600
• Product Code: MAX
• UDI-Device Identifier: 00613994151179
• UDI-Public: 00613994151179
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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: 9732353
• Device Catalogue Number: 9732353
• Device Lot Number: 110930
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1