MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART PLUS CONTRA ANGLE; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number A103200000000

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

In this event it was reported that a x-smart plus contra angle would not hold files.It did not happen during use; no injury resulted.

Manufacturer Narrative

There has been a previous report received 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.After inspection/investigation of device it was found to have various mechanical problems.Device required replacement of head assembly, cartridge and motor casing.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

Manufacturer Narrative

The handpiece was in really bad condition.We replaced the head assembly, cartridge, motor (due to holding mechanism of contra-angle) and casing.

• Brand Name: X-SMART PLUS CONTRA ANGLE
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• 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: 12807733
• MDR Text Key: 285413482
• Report Number: 8031010-2021-00274
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A103200000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• 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