MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART W/CONTRA ANGLE EUR; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number A100400000000

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

In this event it was reported that a x-smart plus contra angle would not hold files.It did not happen during use; no injury resulted.

Manufacturer Narrative

X-smart cartridge.Various mechanical problem.The cartridge is blocked.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.

• Brand Name: X-SMART W/CONTRA ANGLE EUR
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• 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: 12844605
• MDR Text Key: 282103859
• Report Number: 8031010-2021-00362
• Device Sequence Number: 1
• Product Code: EGS
• 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,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A100400000000
• Device Lot Number: 0V937469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/01/2021
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• Type of Device Usage: A
• Patient Sequence Number: 1