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U.S. Department of Health and Human Services

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

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DENTSPLY MAILLEFER X-SMART PLUS ENDO MOTOR WITH CONTRA ANGLE HANPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
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.
 
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Brand NameX-SMART PLUS ENDO MOTOR WITH CONTRA ANGLE HANPIECE
Type of DeviceHANDPIECE, 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 Key8700803
MDR Text Key178543525
Report Number8031010-2019-00079
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodePK
PMA/PMN Number
NA
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA103300000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2019
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 Unkown

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