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

Catalog Number	A100400000000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it is reported that x-smart w/contra angle eur stopped during treatment.No injury.
Additional Manufacturer Narrative
Dentsply sirona china.The handpiece suddenly jammed and could not be used normally.Prolonging the course of treatment and increasing the amount of blood loss in the treatment.Event cause analysis description mentioned by doctor: product reason.This issue has been reported as serious adverse event in china ae monitoring system.Information from ds china maintenance center: goods issue date: 2021-09; within warranty: yes; maintenance record: the customer did not send for repair after occurrence date.

• Brand Name: X-SMART W/CONTRA ANGLE EUR
• Common Device Name: 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: 18073810
• Report Number: 8031010-2023-00861
• Device Sequence Number: 7759141
• Product Code: EKX
• UDI-Device Identifier: D716XSMARTCA1
• UDI-Public: D716XSMARTCA1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A100400000000
• Device Lot Number: 0A745777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/30/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2020
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown