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

Catalog Number A100400000000

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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-smartcontra angle did not hold files.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Additional information has been received indicating that no injury resulted.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 cartridge.Various mechanical problem.The file is hard to remove.Replaced 1 x x cartridge h1004c5210150 and 1 x x head cap h1004c5210500.

• Brand Name: X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE
• Type of Device: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 12285466
• MDR Text Key: 267158837
• Report Number: 8031010-2021-00171
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1