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

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	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.
Event or Problem Description
Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that the health care professional (hcp) opened and used a new product to complete the surgery.The broken part didn¿t fall in the patient, the instrument was remove from the bone and the hcp could see that the plastic part was broken but still attached.They removed the broken part from the rest of the instrument when the instrument was on the instrument table.It is unknown how the instrument broke.There was no reported impact on patient outcome.

• Brand Name: NAVIGATED NIM-SPINE PEDICLE ACCESS SYSTEM KIT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12539817
• Report Number: 1723170-2021-02383
• Device Sequence Number: 4584135
• Product Code: MAX
• UDI-Device Identifier: 00643169555495
• UDI-Public: 00643169555495
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 03/26/2023
• Device Model Number: 9733497
• Device Catalogue Number: 9733497
• Device Lot Number: 210326K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1