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 female patient about (b)(6) on (b)(6).As the root canal was being done, the tip of the file broke but it was retrieved and disposed of.
Additional Manufacturer Narrative
Investigation: no batch number was provided by the customer.Complaint analysis from the last 12 months identifies one additional complaint for breaking files.That complaint was submitted from the same dentist office.Root cause: no product was returned for investigation and no batch information was provided so a full root cause analysis cannot be performed.The following may be a potential root cause of the file breaking: file is used multiple times; file not heat treated properly to required specifications; excessive force applied by the user; user chose the wrong size file.

• 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: 11019153
• Report Number: 2416455-2020-00007
• Device Sequence Number: 19731698
• 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?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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: 30 YR