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

Catalog Number A066100000300

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.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 sirona.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.

Event Description

In this event it was reported that a start-x tip broke during use; no injury resulted and all the broken parts have been retrieved from the patient's mouth.

• Brand Name: START-X TIP EMS INSERT 3
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, pa ; 8494424
• MDR Report Key: 10478610
• MDR Text Key: 215580586
• Report Number: 8031010-2020-00084
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2020

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: A066100000300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1