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

Catalog Number V040252031025

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.Multiple unsuccessful attempts were made to obtain the patient outcome.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

In this event it was reported that a reciproc blue broke during use; the broken part is remaining in the root canal, outcome of the event is unknown as of this mdr evaluation.

• Brand Name: RECIPROC BLUE FILES, 6X, STERILE
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• MDR Report Key: 12615654
• MDR Text Key: 276134591
• Report Number: 9611053-2021-00285
• 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
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040252031025
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1