MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CANNULATED SOLERA DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9735024

Device Problem Material Integrity Problem (2978)

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

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

This report was submitted for 2 of 2: damaged instruments during the aforementioned procedure.Please refer to mfg.Report# 1723170-2 021-02954 for the first instrument.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used during a spinal procedure.During instrument removal, the two drivers were broken.All pieces were able to be retrieved.The procedure was completed with the use of a third driver to remove.The procedure was delayed briefly (less than one hour) to open another instrument set.The issue was considered resolved.There was no impact on patient outcome.

• Brand Name: CANNULATED SOLERA DRIVER
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13078911
• MDR Text Key: 282724354
• Report Number: 1723170-2021-02956
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9735024
• Device Catalogue Number: 9735024
• Device Lot Number: 190108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Date Device Manufactured: 01/08/2019
• 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
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 90 KG