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 03/27/2023

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.Investigation results: as per service engineer.Head cap - problem.Cartridge - problem.Neck- problem.Under warranty invoice no.1370 dated (b)(6) 2021.Problem investigation- cartridge neck and cap  defective- replaced cartridge, head cap, neck.

Event Description

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

• 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: 16643141
• MDR Text Key: 312325007
• Report Number: 8031010-2023-00777
• 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
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A100400000000
• Device Lot Number: 0A745642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2023
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1