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

Catalog Number V040252025025

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The involved reciproc blue file is actually broken at the tip of the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.Nothing unusual to report was found during dhrs review.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

In this event it was reported that a reciproc blue broke during use; the outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

Additional information received indicates the broken portion of the file will be incorporated into he root canal filling.The involved reciproc blue file r25 8/100 25mm 025 is actually broken at the tip of the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.Nothing unusual to report was found during dhrs review (batches #1675496, #1675495, #1675494, #1677633, #1675497, #1675724, and #1676388).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: 12727872
• MDR Text Key: 279289077
• Report Number: 9611053-2021-00350
• 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: 346298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1