MAUDE Adverse Event Report: DENTSPLY MAILLEFER RS PENETRATION DRILL; DRILL, DENTAL, INTRAORAL

Catalog Number C010120000100

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received 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 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 rs penetration drill separated during use.The outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

Involved rs penetration drill 1 that broke during use was not returned, no analysis of the fragments can be made.Nothing unusual to report was found during dhr review (batch #1563126).For information, product design and manufacturing process are unchanged since 2007.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: RS PENETRATION DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 10377070
• MDR Text Key: 205972846
• Report Number: 8031010-2020-00140
• Device Sequence Number: 1
• Product Code: DZA
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C010120000100
• Device Lot Number: 1563126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Date Manufacturer Received: 07/07/2020
• Patient Sequence Number: 1