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

Catalog Number A066100000300

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

The involved start-x tip ems inserts 3 that broke during use were not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1508351).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.For information, we noted that the returned device had a worn active part.Multiple unsuccessful attempts were made to obtain the patient outcome.

• 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: 8960539
• MDR Text Key: 156738964
• Report Number: 8031010-2019-00161
• 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: 10/08/2019

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
• Device Lot Number: 1508351
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1