FDA Adverse Event Malfunction Summary report: N

WAVEONE GOLD RECIPROCATING FILE PRIMARY 21MM

MDR report key: 9550245 · Received January 6, 2020

Report

Report Number: 2320721-2019-00283
Event Type: Malfunction
Date Received: January 6, 2020
Report Date: March 4, 2020
Manufacturer: TULSA DENTAL PRODUCTS LLC
Product Code: EKS
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: DENTIST

Narratives

Additional Manufacturer Narrative · 0

CUSTOMER RETURNED TWO PACKS. PACKS RETURNED IN AUTOCLAVE BAG MELTED TOGETHER. THE PACKAGING OF BOTH THE OUTSIDE AND INSIDE SLEEVES WERE MELTED TOGETHER. UNKNOWN IF THIS WAS DONE AT THE OFFICE OR RETURNS DEPARTMENT. NO BROKEN FILE RETURNED. TESTING PERFORMED BY MANUFACTURING / LORI OGLE : PARTS ARE VISUALLY NORMAL DUE TO THE CONDITION IN WHICH THE FILES WERE RETURNED ONLY ABLE TO MEASURE TWO FILES AND ONE COULD NOT BE MEASURED AT 3 MM. SPEC @ 3MM-.470 +/-.020 9MM-.845 +/-.030 1) .459 MM .845 MM. 2) / .840 MM. BASED ON WHAT WAS MEASURED FILES MET SPECIFICATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW.

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 FILE BROKE DURING USE. THE FILE WAS NOT RETRIEVED BUT WAS INCORPORATED AS PART OF THE FILLING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
18782	WAVEONE GOLD RECIPROCATING FILE PRIMARY 21MM	FILE, PULP CANAL, ENDODONTIC	EKS	TULSA DENTAL PRODUCTS LLC	NA	192513

Patients

Seq	Age	Sex	Outcome	Treatment
1