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

Catalog Number A100400000000

Device Problem 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 with 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.Received - 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.Replaced 1 x x head cap h1004c5210500.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

Event Description

In this event it was reported that a x-smart contra angle won't hold files; no injury resulted.

• 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
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, 322-8 666; JA 322-8666
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 11258068
• MDR Text Key: 231789773
• Report Number: 8031010-2020-00124
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K990682
• 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
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1