MAUDE Adverse Event Report: DENTSPLY MAILLEFER GATES RA 32MM 1; DRILL, DENTAL, INTRAORAL

Catalog Number A000824000100

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

Patient Problem No Consequences Or Impact To Patient (2199)

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.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 three gates drills separated; no injury resulted.The broken parts have been retrieved.

Manufacturer Narrative

The two gates ra 32mm 1 returned in loose are actually broken at the base of the neck portion (expected breakage area).No material defect was found during analysis of the rupture patterns.Unused product has been evaluated according to iso standard and meets expectations.Nothing unusual to report was found during dhr review (batch #1476046).Root causes are not identified.This kind of event is tracked and we monitor the trend.

• Brand Name: GATES RA 32MM 1
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 8596922
• MDR Text Key: 144694426
• Report Number: 8031010-2019-00045
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A000824000100
• Device Lot Number: 1476046
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2019
• Patient Sequence Number: 1