MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANPIECE; HANDPIECE, DIRECT DRIVE, AC-POWERED

Catalog Number A100400000000

Device Problems Fitting Problem (2183); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received for a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.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 a x-smart would not hold files; no injury resulted.

Manufacturer Narrative

Received - 1x x-smart cartridge h1004c5210150.1x x-smart neck h1004c5470220.1x x-smart head cap h1004c5210500.X-smart head cap: bad maintenance (user).The file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.X-smart neck: rotation not fluid.X-smart cartridge: rotation not fluid.

• Brand Name: X-SMART ENDO MOTOR WITH CONTRA ANGLE HANPIECE
• Type of Device: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 8856639
• MDR Text Key: 178547630
• Report Number: 8031010-2019-00120
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• PMA/PMN Number: K990682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A100400000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1