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

Catalog Number A100400000000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that a x-smart w/contra angle eur won't hold files.No injury occurred.

Manufacturer Narrative

Investigation results: x-smart w/contra angle eur as per customer- sound and file not holding as per service engineer- h1004c5210150 - cartridge x s-problem h1004c5210500 - head cap -problem h1004c5470220 - neck-x- problem investigation result -cartridge neck and cap defective - replaced following agreement with the after sales service, dentsply sirona india will not return the product.A credit note will be issued for the spare parts replaced by the indian repair center.Credit note issued for h1004c5210150, 1 x h1004c5210500 and 1 x h1004c5470220.

• Brand Name: X-SMART W/CONTRA ANGLE EUR
• Type of Device: HANDPIECE, 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 Key: 16530423
• MDR Text Key: 311230120
• Report Number: 8031010-2023-00762
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A100400000000
• Device Lot Number: 8448190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/02/2023
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1