MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATED NIM-SPINE PEDICLE ACCESS SYSTEM KIT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	9733497
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
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 used during a sacroiliac and thoracolumbar procedure.It was reported that the handle of needle broke off the cannula while being hammered into pedicle of lumbar spine.There was no reported harm to the patient present, and there was a delay of less than one hour.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Add'l information was received.It was actually just the locking mechanism on the top of the cannula where it attaches to the navigated nim handle that broke.The pedicle was particularly hard bone and dr (b)(6) was trying to extract the cannula with the nav handle (there is no other handle supplied to remove it).He applied a twisting motion to the handle which broke the connection.He did this subsequently with two more nav pak needles.No harm or injury was done to the patient.The cannula was eventually extracted with a roberts forceps and mallet.

• Brand Name: NAVIGATED NIM-SPINE PEDICLE ACCESS SYSTEM KIT
• 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: 10879836
• Report Number: 1723170-2020-03058
• Device Sequence Number: 3254638
• Product Code: MAX
• UDI-Device Identifier: 00643169555495
• UDI-Public: 00643169555495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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 Expiration Date: 12/08/2021
• Device Model Number: 9733497
• Device Catalogue Number: 9733497
• Device Lot Number: 191209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR