FDA Adverse Event Malfunction Summary report: N

WAVEONE GOLD RECIPROCATING FILE SMALL 21MM

MDR report key: 9205087 · Received October 17, 2019

Report

Report Number: 2320721-2019-00213
Event Type: Malfunction
Date Received: October 17, 2019
Report Date: January 15, 2020
Manufacturer: TULSA DENTAL PRODUCTS LLC
Product Code: EKS
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VT, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

CUSTOMER RETURNED 2 UNOPENED FILES IN BLISTER CELL PACKAGING AND 1 BROKEN FILE IN AN AUTOCLAVE BAG FROM LOT#0000198342. USING MICROSCOPE VISUALLY CHECKED FILES. NO MANUFACTURING DEFECTS OR MARKINGS NOTED ON FILES. THE FILE FROM THE AUTOCLAVE BAG IS BROKEN APPROXIMATELY 4.5MM FROM THE TIP. LORI OGLE MEASURED THE 2 UNOPENED FILES USING TM-0061 ON NIKON 4. RETURNED PRODUCT HAS BEEN ANALYZED AND WAS FOUND IN COMPLIANCE WITH SPECIFICATIONS. NO FAULT FOUND WITH RETURNED FILES. ROOT CAUSE OF FILE BREAKAGE IS UNKNOWN.

Additional Manufacturer Narrative · 1

AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem · 1

IN THIS EVENT IT WAS REPORTED THAT A WAVEONE GOLD SMALL FILE BROKE IN A PATIENT'S TOOTH DURING USE. THE BROKEN PIECE COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
999941	WAVEONE GOLD RECIPROCATING FILE SMALL 21MM	FILE, PULP CANAL, ENDODONTIC	EKS	TULSA DENTAL PRODUCTS LLC	NA	0000198342

Patients

Seq	Age	Sex	Outcome	Treatment
1