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

Catalog Number C009900000000

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

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 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 a penetration drill separated after one use.The outcome of the event is unknown as of this mdr evaluation.

Manufacturer Narrative

The returned instrument is broken at the base of the active part.No material defect was found during analysis of the rupture pattern.No unused instrument is available for evaluation.Nothing unusual to report was found during dhr review.Root causes are not identified.We will track this kind of event and monitor the trend.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: PENETRATION DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 8219662
• MDR Text Key: 132214836
• Report Number: 8031010-2018-00161
• 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: 02/15/2019

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: C009900000000
• Device Lot Number: 1/1509935
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 02/15/2019
• Patient Sequence Number: 1