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

Catalog Number A103200000000

Device Problems Detachment of Device or Device Component (2907); Data Problem (3196)

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.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 plus contra angle won't hold files; no injury resulted.

Manufacturer Narrative

X-smart plus drive shaft, bad maintenance (user), there is some foreign matter on the drive shaft.X-smart plus cartridge, various mechanical problem, the ball bearing of the cartridge is broken.(the balls are more in the ball bearing).Replaced 1 x xp cartridge h1033c1051015 and 1 x xp drive shaft h1033c1051022.

• 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
• MDR Report Key: 10543671
• MDR Text Key: 208385734
• Report Number: 8031010-2020-00180
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1