MAUDE Adverse Event Report: DENTSPLY MAILLEFER EASYPOST PRECISION DRILL 2; DRILL, DENTAL, INTRAORAL

Catalog Number C060100000200

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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 returned easypost precision drill 2 is actually broken at the base of the operating part.No wear off was noted.No material defect was found during analysis of the rupture pattern.The batch number is unknown, dhr cannot be reviewed.Root causes are not identified notably because the circumstances in which the instrument broke remain unclear.As the operating part is slightly curved, the instrument might have broken during an attempt from a user to straighten it.We will track this kind of event and monitor the trend.

Event Description

In this event it was reported that an easypost precision drill broke.No patient was injured and no parts remained in the mouth.

• Brand Name: EASYPOST PRECISION DRILL 2
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 9205088
• MDR Text Key: 178586434
• Report Number: 8031010-2019-00221
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C060100000200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1