MAUDE Adverse Event Report: DENTSPLY MAILLEFER START-X TIP; SCALER, ULTRASONIC

Catalog Number A066000000300

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that a start-x tip broke during use; no injury resulted.

Manufacturer Narrative

Returned start-x tip satelec insert 3 is broken in the active part.No material defect was found during analysis of the rupture pattern.The device shows no mark of excessive usury.Nothing unusual to report was found during dhr review (batch #1559965).The customer said having set his ultrasonic device at a power of 70.According to the dfu, the recommended power setting for start-x insert 3 connected to a satelec p5 newtron must be between 10 and 18.In all likelihood, the ultrasonic device used by the customer is not of this model, so we cannot attest that the selected setting complies maillefer recommendations.The root causes of the breakage are not identified.We will track this kind of event and monitor the trend.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

• Brand Name: START-X TIP
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 9776034
• MDR Text Key: 184850012
• Report Number: 8031010-2020-00028
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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 Operator: Health Professional
• Device Catalogue Number: A066000000300
• Device Lot Number: 1559965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1