MAUDE Adverse Event Report: VDW GMBH RECIPROC BLUE FILES, 6X, STERILE; 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 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 device is available for evaluation, though results are not available 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.

Event Description

It was reported that reciproc blue file broke, no patient injury, broken part removed from canal.Update from questionnaire received, broken part remained in root canal.Patient was sent to endo specialist for removal of broken part.Treatment not yet concluded.

Manufacturer Narrative

The returned file is broken in the active part (uncertain conditions).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 #1648098, #1648622, #1649159 and #1648375).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).Root causes are not identified.

• 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: 12927474
• MDR Text Key: 283242483
• Report Number: 9611053-2021-00424
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V040252025025
• Device Lot Number: 329607, 358633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/12/2021
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1