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

Catalog Number V040212025025

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.This report is for the fourth device.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 four reciproc blue files broke during use at different patients.In the first event the customer suspected counterfeit product.Fragment remains in root canal.Tooth is filled with fragment.This report is for the fourth device.

Manufacturer Narrative

Involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhrs review (batches #1445372, #1444795, #1445002, #1445369, #1444989 and #1444776).Root causes are not identified.We will track this kind of event and monitor the trend.For information, complaints (b)(4) are not the first complaints received involving this vdw batch number.Through previous complaint (b)(4), we had received a blister pack of reciproc files r25 8/100 25mm 025 batch #221594 which had been analyzed and had been recognized as counterfeited products.

• Brand Name: RECIPROC FILES 6X
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer (Section G): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 12732173
• MDR Text Key: 281023981
• Report Number: 9611053-2021-00361
• 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: 01/20/2022

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: V040212025025
• Device Lot Number: 221594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1