MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYFLEX CM FILE ASST 25MM; ENDODONTIC FILE

Model Number	H825ASST
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Assistant at the office said that the doctor performed a root canal procedure on a male patient either (b)(6) or (b)(6)years old.While the doctor was performing the root canal, the tip of the file broke, but it was not able to be retrieved, and the piece that broke was left in the patient's canal.The patient did not report any discomfort.
Additional Manufacturer Narrative
Investigation results: no batch number was provided by the customer.The returned file was inspected by the materials science engineer.He noted that there are no internal defects that would blame the file material.He noted the break is from torsion starting on the surface and propagating from there.Based on the evaluation of the returned material the most likely root cause is that the user is using the files too many times or applying excessive force or selecting the wrong size.

• Brand Name: HYFLEX CM FILE ASST 25MM
• Common Device Name: ENDODONTIC FILE
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 10983935
• Report Number: 2416455-2020-00006
• Device Sequence Number: 3241856
• Product Code: EKS
• UDI-Device Identifier: D661H825ASST1
• UDI-Public: D661H825ASST1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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 Model Number: H825ASST
• Device Catalogue Number: H825ASST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR