FDA Adverse Event Malfunction Summary report: N

HYFLEX CM FILE 04/15, 25MM 6PK

MDR report key: 9916886 · Received April 2, 2020

Report

Report Number: 2416455-2020-00005
Event Type: Malfunction
Date Received: April 2, 2020
Date of Event: January 7, 2020
Report Date: January 7, 2020
Manufacturer: COLTENE WHALEDENT INC.
Product Code: EKS
UDI-DI: D661H82504151
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
380403	HYFLEX CM FILE 04/15, 25MM 6PK	ENDODONTIC FILE	EKS	COLTENE WHALEDENT INC.	H8250415	J73540	D661H82504151

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention