MAUDE Adverse Event Report: DIROS TECHNOLOGY INC RF TRIDENT CANNULA

Model Number	DTR-018/54/5
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative for fda report - (b)(4).Neither of the following outcomes resulted from the incident: death, life threatening situation, hospitalization, serious medical event, disability/permanent damage, congenital anomaly/birth defect, and required intervention to prevent permanent impairment/damage to the patient.When the device is received and additional information becomes available, further investigation will be completed and a follow-up report will be issued.
Event or Problem Description
It was reported to the manufacturer that after successfully performing 2 lesions for the supero-medial genicular nerve, upon retracting the cannula, a small piece about 1-2 mm from the distal part of one of the 3 tines was missing.Under fluoroscopic imaging, a tiny metallic point was observed near the site of lesioning.Subsequently, the patient was informed and agreed not to remove it.The procedure went on with a new cannula for the last lesion, the infero-medial genicular nerve without issue.It is expected that the device will be returned to the manufacturer along with fluoroscopic imaging for further analysis and to continue the investigation.
Additional Manufacturer Narrative
Investigation of the device has shown that the damage to the tine has resulted from excessive mechanical force being applied on it during placement.Distinctive dents on the internal surface of the primary bevel are indicative of the movement of the device with partially deployed tines.Examination of the cross section of the broken tine doesn't show any damage or material defects.The incident was caused by improper usage of the device; the user did not follow the warnings and instructions provided in the ifu for the device.

• Brand Name: RF TRIDENT CANNULA
• Common Device Name: CANNULA
• Manufacturer (Section D): DIROS TECHNOLOGY INC; 120 gibson drive; markham, ontario L3R 2 Z3; CA L3R 2Z3
• MDR Report Key: 11072230
• Report Number: 8043398-2020-00001
• Device Sequence Number: 19757639
• Product Code: GXI
• UDI-Device Identifier: 00825114004597
• UDI-Public: 00825114004597
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: DTR-018/54/5
• Device Catalogue Number: DTR-018/54/5
• Device Lot Number: 4766
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR