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); Therapeutic or Diagnostic Output Failure (3023)

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 would not hold files.No injury resulted.

Manufacturer Narrative

X-smart plus cartridge: bad maintenance (user), there is some rust on the cartridge.X-smart plus wave washer: various mechanical problem, rusted.X-smart plus bearing retainer: various mechanical problem, rusted.X-smart plus head cap: various mechanical problem, rusty.X-smart plus drive shaft: various mechanical problem, rotation not fluid.X-smart plus head assembly other rust.Replaced 1 x xp head cap h1033c1051050, 1 x xp bearing retainer h1033c1051113, 1 x xp cartridge h1033c1051015, 1 x xp wave washer h1033c427a360, 1 x xp drive shaft h1033c1051022 and 1 x xp head assembly h1033c1051011.

• 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: 11418671
• MDR Text Key: 243702444
• Report Number: 8031010-2021-00028
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1