MAUDE Adverse Event Report: DENTSPLY MAILLEFER WAVEONE GOLD FILE; FILE, PULP CANAL, ENDODONTIC

Catalog Number UNKNOWN-CON

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 device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Event Description

In this event it was reported that a waveone gold file broke during use.The patient has been referred to an endo specialist but the separated piece was not retrieved and was incorporated into the filling.No injury resulted.

• Brand Name: WAVEONE GOLD FILE
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 12685597
• MDR Text Key: 278112374
• Report Number: 8031010-2021-00252
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-CON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1