MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYFLEX CM FILE 04/15, 25MM 6PK; ENDODONTIC FILE

Model Number	H8250415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer states the 04/15 file broke.The broken file was not returned; only extras in the package.Complaint analysis for the last 12 months indicates this is the only complaint for this part number.Both batch records were reviewed for each file manufacturing.There were no issues identified that indicate a manufacturing defect was present.Root cause: the broken file was not returned; only the extra files in the kit.A review of the batch records confirms the files met all specification requirements.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.4) user chose the wrong size file.
Event or Problem Description
Initial information provided 01/07/2020: "doctor purchased hyflex cm files.A 04/15 file broke." additional information provided by the dental office on 03/23/2020: how was file being used when it broke? in rotary handpiece.Did it break in the patient's mouth/tooth? yes, in the tooth.Was there any injury? no.Was the file able to be retrieved? no.Did the removal require surgical intervention? no.

• Brand Name: HYFLEX CM FILE 04/15, 25MM 6PK
• Common Device Name: ENDODONTIC FILE
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls, oh
• MDR Report Key: 9916886
• Report Number: 2416455-2020-00005
• Device Sequence Number: 19524074
• Product Code: EKS
• UDI-Device Identifier: D661H82504151
• UDI-Public: D661H82504151
• Combination Product (Y/N): N
• 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): 01/07/2020

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 Model Number: H8250415
• Device Catalogue Number: H8250415
• Device Lot Number: J73540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/02/2020
• 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