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

Model Number	9733498
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned for analysis.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 intra/peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that pedicle access kit (pak) needle was damaged while pulling instrument out from the bone.The reports that the hind end of the instrument became separated from the rest of the instrument.There was no delay in the procedure and no impact on patient outcome.The site was able to retrieve the broken instrument with a heavy clamp without any issues.The likely cause of the issue was due to excessive hammering on the instrument.

• Brand Name: NAVIGATED PEDICLE ACCESS 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: 11324108
• Report Number: 1723170-2021-00391
• Device Sequence Number: 4125643
• Product Code: MAX
• UDI-Device Identifier: 00613994475169
• UDI-Public: 00613994475169
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131425
• 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): 02/12/2021

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: 09/14/2022
• Device Model Number: 9733498
• Device Catalogue Number: 9733498
• Device Lot Number: 200914A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 84