MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL START-X TIP EMS INSERT 3; SCALER, ULTRASONIC

Catalog Number A066100000300

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

In this event it is reported that start-x tip ems insert 3 broke during use.No injury occurred.

Manufacturer Narrative

While no serious injury resulted in this event, 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.

Manufacturer Narrative

Summary: a start-x tip ems insert 3 was returned in loose.Device is broken in the middle of the active part.No material defect was found during analysis of the rupture pattern.No unused device is available for further evaluation.Nothing unusual to report was found during dhr review (batch #1835117).We cannot rule on the compliance of the power settings selected by the customer in comparison with the ones recommended by maillefer which are exclusively given for ems generators.Root causes are not identified.We will track this kind of event and monitor the trend.Generally speaking, several other factors may contribute to breakage issue, such as usury, pressure or incorrect technique.All of these factors may affect the longevity of the tip.

• Brand Name: START-X TIP EMS INSERT 3
• 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: 18856921
• MDR Text Key: 337784662
• Report Number: 8031010-2024-00021
• 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: 05/01/2024

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: A066100000300
• Device Lot Number: 1835117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/05/2024
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1