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

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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it was reported that a start-x tip broke.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused device is available for evaluation.Nothing unusual to report was found during dhr review (batch#: 1365834).No information was given regarding technique, we cannot rule on its compliance with (b)(6) recommendations.Root causes are not identified.We will track this kind of event and monitor the trend.Additional information received indicating that no injury resulted.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: 9821937
• MDR Text Key: 185719972
• Report Number: 8031010-2020-00034
• 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: 1365834
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1