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

Catalog Number V040252025025

Device Problem Break (1069)

Patient Problem 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 returned reciproc blue file is broken at the base of the active part (fatigue).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 dhr review.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).

Event Description

In this event it was reported that a reciproc blue broke during use; no injury reported.Outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

The broken file could be removed from the canal with help of a root end surgery.Root canal of affected tooth was then filled with post and finalized with a crown.

• Brand Name: RECIPROC BLUE FILES, 6X, STERILE
• 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: 12736241
• MDR Text Key: 279541256
• Report Number: 9611053-2021-00356
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040252025025
• Device Lot Number: 352755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1