MAUDE Adverse Event Report: DENTSPLY MAILLEFER EASYPOST PRECISION DRILL 1; DRILL, DENTAL, INTRAORAL

Catalog Number C060100000100

Device Problems Material Disintegration (1177); Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where breakage resulted in a serious injury with a similar device.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 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 an easypost precision drill left metal chips in the root canal.The metal chips have been removed by the dentist and the patient was not injured.

Manufacturer Narrative

The batch number is unknown, dhr cannot be reviewed.The returned drill is worn out, the cutting edges are blunt.The material worked by the practitioner may have been harder than dentine (possible contact with metallic or ceramic reconstitution).For information, the instrument has the required hardness specified on the current drawing.Root causes are not identified.We will track this kind of event and monitor the trend.

• Brand Name: EASYPOST PRECISION DRILL 1
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 7975860
• MDR Text Key: 126104113
• Report Number: 8031010-2018-00123
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C060100000100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/13/2018
• Patient Sequence Number: 1