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

Catalog Number V040252025025

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

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.

Event Description

It was reported that four reciproc blue files broke during use by three different dentist; all broken at approximate 16 mm length, all broken parts not removable.Request for update and outcome of pending treatments.Blister pack is to be forwarded.

Manufacturer Narrative

Involved product that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhrs review (batches #1702917, #1703250, #1703364, #1703205 and #1703369).Unused reciproc blue files r25 8/100 25mm 025 were evaluated and were found in compliance with specifications.According to our prescriptions, we can consider that the production vdw batch #359748 is conforming (representative sampling).No fault was found, production meets specifications.

• 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: 12920609
• MDR Text Key: 281684533
• Report Number: 9611053-2021-00419
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V040252025025
• Device Lot Number: 359748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• 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
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1