MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYFLEX CM FILE ASST 31MM; ENDODONTIC FILE

Catalog Number	60018460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All batch records were reviewed.There were no issues identified that indicate a manufacturing defect was present.Root cause: no product was returned for investigation so a full root cause analysis cannot be performed.As identified in the product risk file, (b)(4), 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.
Event or Problem Description
Doctor was using our hyflex cm files and experience separation in the canal on the first use of the file.The file had not been used prior to this case and was brand new.Doctor complains that upon torsional load of less than 2.5ncm (he had his torque rating properly set) the file separated at the stop section.It did not separate at the mandrel but instead about 2mm down from where the spiral part of the file begins.It was file 04/25 that broke from the set.There was no patient injury.The customer later indicated that the event happened during procedure and he had hand filed.He said he hand files for every case.The doctor indicated size 15, but did not recall if he used our glidepath file.The doctor had to buy a third party instrument in order to remove the separated file.

• Brand Name: HYFLEX CM FILE ASST 31MM
• Common Device Name: ENDODONTIC FILE
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 9579310
• Report Number: 2416455-2020-00001
• Device Sequence Number: 13535100
• Product Code: EKS
• UDI-Device Identifier: D661600184601
• UDI-Public: D661600184601
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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 Catalogue Number: 60018460
• Device Lot Number: I85846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/11/2020
• 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: Required Intervention