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 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

No products have been returned to medtronic for analysis.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 during wide bilateral decompressive laminectomies at l1-2, 2-3, 3-4, 5-s1, and bilateral fusion with autograft onlay facet arthrodesis fusion with stereotactic neuro navigation, the tip of the screwdriver broke off.The tip was retrieved and verified.There was no reported delay to the procedure.There were no patient symptoms or complications reported as a result of this event.

• 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: 12700885
• MDR Text Key: 278533112
• Report Number: 1723170-2021-02569
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9735024
• Device Catalogue Number: 9735024
• Device Lot Number: 161105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2016
• 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: 50 YR