MAUDE Adverse Event Report: DENTSPLY MAILLEFER K-FLEXOFILE COLORINOX 25MM 15-40; FILE, PULP CANAL, ENDODONTIC

Catalog Number A012C02590000

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

While no injury was reported for this event, as a result of this malfunction, the potential for surgical intervention exists (although it is inadvisable per expert opinion provided by dr.(b)(6)) to preclude injury or illness that would necessitate medical or surgical intervention 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 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a k-flexofile colorinox separated.The outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

After analysis, the returned files do not meet maillefer quality standards and are obviously counterfeit.Moreover, the batch number has no corresponding with the reference (b)(4) in our system.The container and its labelling are equally recognized as fakes.We have no responsibility regarding this product.

• Brand Name: K-FLEXOFILE COLORINOX 25MM 15-40
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6769101
• MDR Text Key: 82032746
• Report Number: 8031010-2017-00086
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A012C02590000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1