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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED

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MAILLEFER INSTRUMENTS HOLDING SARL X-SMART W/CONTRA ANGLE EUR HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number A100400000000
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2021
Event Type  malfunction  
Event Description
In this event it has been reported that x-smart w/contra angle won't hold files. There was no injury to patient.
 
Manufacturer Narrative
In this event it was reported that a contra angle won't hold files; no injury resulted. 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. After inspection, replaced cartridge, head cap and hand piece.
 
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Brand NameX-SMART W/CONTRA ANGLE EUR
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
MAILLEFER INSTRUMENTS HOLDING SARL
ch. du verger 3
ballaigues vaud CH-13 38
SZ CH-1338
Manufacturer (Section G)
MAILLEFER INSTRUMENTS HOLDING SARL
ch. du verger 3
ballaigues vaud CH-13 38
SZ CH-1338
Manufacturer Contact
hannah seevaratnam
221 west philadelphia st.
york, PA 17401
7178457511
MDR Report Key13229445
MDR Text Key285337341
Report Number8031010-2022-00416
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K990682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 01/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberA100400000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2021
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date12/17/2021
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

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