MAUDE Adverse Event Report: RECIPROC BLUE FILES, 6X; FILE, PULP CANAL, ENDODONTIC

Catalog Number V040252025025

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

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 two involved reciproc blue files are actually broken at the tip of the active part (fatigue).No material defect was found during analysis of the rupture patterns.Nothing unusual to report was found during dhrs review.Unused files have been evaluated and were found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.For information, we remind the practitioner has to make sure that a straight-line access is created prior using the reciproc blue files (as mentioned in the dfu).

Event Description

This report is for the 1st device - 1 of 2.In this event it was reported that two reciproc blue files broke during use at same patient; broken parts not removed yet.Update to be requested.Outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

Two unifiles 5/100 25mm 015 have been returned (one file in loose + one unused file).The file in loose is actually broken at the tip of the active part (uncertain conditions).No material defect was found during analysis of the rupture pattern.Nothing unusual to report was found during dhrs review (batches #1646899, #1646888 and #1649161).Unused file has been evaluated and was found in compliance with specifications.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: RECIPROC BLUE FILES, 6X
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• MDR Report Key: 12727868
• MDR Text Key: 279303126
• Report Number: 9611053-2021-00353
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040252025025
• Device Lot Number: 356062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1