MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL START-X TIP EMS INSERT 2; SCALER, ULTRASONIC

Catalog Number A066100000200

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that start-x tip ems insert 2 broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

There has been a previous report received 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.

Manufacturer Narrative

Additional information received for the outcome of this event: no injury occurred.All broken parts have been recovered from patient's mouth.No further treatment required.Summary: returned start-x tip ems insert 2 is actually broken in the curved portion of the operating part.No material defect was found during analysis of the rupture pattern.Cutting edges are strongly worn out.No unused device is available for further evaluation.Nothing unusual to report was found during dhr review (batch #(b)(4)).Through our website, we find the settings recommended by maillefer for different ems generators but not for the generators from other brands, as the one used by the customer.We cannot rule on the compliance of the customer's settings with the ones recommended by maillefer.Root causes are not identified.We will track this kind of event and monitor the trend.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code -4580 health effect - impact code - 4648 the correct codes for this complaint are: health effect - clinical code -4582 health effect - impact code - 2199 this is a follow up report to correct these codes.

• Brand Name: START-X TIP EMS INSERT 2
• Type of Device: SCALER, ULTRASONIC
• 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: 17852444
• MDR Text Key: 324705178
• Report Number: 8031010-2023-00850
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/20/2023

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: A066100000200
• Device Lot Number: 1795719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/19/2023
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1