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

Catalog Number A066100000300

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The broken section was present.However, because breakage can result in a serious injury, this event is reportable per 21 cfr 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 has not been returned 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 has been discovered broken when removed from the autoclave; no patient has been involved.

Manufacturer Narrative

Returned start-x tip ems insert 3 is actually broken in the active part.No material defect was found during analysis of the rupture pattern.No unused device is available for evaluation.Nothing unusual to report was found during dhr review (batch #1591163).No information was given regarding technique, we cannot rule on its compliance with maillefer's recommendations.Root causes are not identified.We will track this kind of event and monitor the trend.

• 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: 9573184
• MDR Text Key: 178744203
• Report Number: 8031010-2019-00303
• 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: 03/02/2020

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
• Device Lot Number: 1591163
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1