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

Catalog Number A103300000000

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.X-smart plus head assembly: sav bad maintenance (user).Head assembly is scratched.X-smart plus cartridge: sav various mechanical problem, makes an unusual noise and the movement is not fluid.X-smart plus head cap: sav various mechanical problem, the push button is blocked.X-smart plus bearing retainer: sav various mechanical problem, broken h1033c1051113.X-smart plus wave washer: sav various mechanical problem, rusted.X-smart plus drive shaft: sav various mechanical problem, rotation not fluid.

Event Description

In this event it was reported that a x-smart plus contra angle locked and stopped working during the procedure of root canal treatment; no injury resulted.

• Brand Name: X-SMART PLUS ENDO MOTOR WITH CONTRA ANGLE HANPIECE
• 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: 8700803
• MDR Text Key: 178543525
• Report Number: 8031010-2019-00079
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A103300000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 05/16/2019
• 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