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

Model Number 9733497

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10879836
• MDR Text Key: 221285119
• Report Number: 1723170-2020-03058
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169555495
• UDI-Public: 00643169555495
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR