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

Catalog Number A100400000000

Device Problems Mechanical Problem (1384); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction has caused file separation. Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr 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 the handpiece of a x-smart rotated with resistance ; 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: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 12671783
• MDR Text Key: 280060494
• Report Number: 8031010-2021-00235
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: A100400000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No