MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for DT UNIVERSAL DRILL V040935000 manufactured by Recherches Techniques Dentaires (r.t.d.).
[140151440]
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.
Patient Sequence No: 1, Text Type: N, H10
[140151441]
It was reported that a dt universal drill broke during use. The broken part was retrieved and no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001226627-2016-00001 |
| MDR Report Key | 8434542 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date Mfgr Received | 2016-02-25 |
| Date Added to Maude | 2019-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) |
| Manufacturer Street | 3 RUE LOUIS NEEL |
| Manufacturer City | ST. EGREVE ISERE, 38120 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DT UNIVERSAL DRILL |
| Generic Name | DRILL, DENTAL, INTRAORAL |
| Product Code | DZA |
| Date Received | 2019-03-19 |
| Returned To Mfg | 2016-02-25 |
| Model Number | NA |
| Catalog Number | V040935000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) |
| Manufacturer Address | 3 RUE LOUIS NEEL ST. EGREVE ISERE, 38120 FR 38120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |