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

Catalog Number V040252025025

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

It was reported that a reciproc blue file broke.Broken part remained in root canal, they will check the tooth in 3 months by x-ray.Broken part still remains in root canal, using medicine treatment 1st and then root filling.Treatment not yet concluded as of this report.

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 device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Manufacturer Narrative

Two reciproc blue files r25 8/100 25mm 025 were returned (one file in loose + one unused file).The file in loose is actually broken at the tip of the active part (torque + fatigue).No material defect was found during analysis of the rupture pattern.Nothing unusual to report was found during dhr review (batch #1665952).Unused file was evaluated and was 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).

• Brand Name: RECIPROC BLUE FILES, 6X, STERILE
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer (Section G): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 12951355
• MDR Text Key: 283392894
• Report Number: 9611053-2021-00428
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V040252025025
• Device Lot Number: 339197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/17/2021
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1