MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734683

Device Problem Material Integrity Problem (2978)

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

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to (b)(4) patient privacy regulations.The instrument tracker was returned to the manufacturer for evaluation.Testing found that a side tab on the unit had broken off and was missing.Otherwise, the unit was found to be fully functional and tracked as intended.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that the instrument tracker was broken.No further details were received.No delay to the case.No impact on patient outcome.Additional information was received stating that the instrument was not damaged inside of the patient anatomy it was found during "mdr".The part that was broken it the part that hold the instrument.

• Brand Name: NAVLOCK
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 11118308
• MDR Text Key: 225256398
• Report Number: 1723170-2021-00026
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734683
• Device Catalogue Number: 9734683
• Device Lot Number: 190806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1