MAUDE Adverse Event Report: RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) DT UNIVERSAL DRILL; DRILL, DENTAL, INTRAORAL

Catalog Number V040935000

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 with a similar device 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.Investigation results received: the sem investigation did not show or detect defect in the material.According to vdw, the customer followed the procedure by using a canal root preparation and low speed as recommended 1000-200 pm.However in absence of clinical procedure details asked by e-mail dated on (b)(6) 2016, it is difficult to determine the exact reason.The dark/back at the broken part may suggest to think that the drill was blocked (for undetermined reason) when during the drilling operation.This submission is being made after an acquisition and internal audit of rtd.

Event Description

It was reported that a dt universal drill broke during use.The broken part was retrieved and no injury resulted.

• Brand Name: DT UNIVERSAL DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• Manufacturer (Section D): RECHERCHES TECHNIQUES DENTAIRES (R.T.D.); 3 rue louis neel; st. egreve isere, 38120 ; FR 38120
• Manufacturer (Section G): RECHERCHES TECHNIQUES DENTAIRES (R.T.D.); 3 rue louis neel; st. egreve isere, 38120 ; FR 38120
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 8434542
• MDR Text Key: 140151440
• Report Number: 3001226627-2016-00001
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040935000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1