MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-02 for CALIBRATION DRILL V040925000001 manufactured by Dentsply Vdw Gmbh.
[66687961]
There has been a previous report received where this malfunction in a similar device 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. Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply (b)(4). The involved drill is actually broken in the middle of the smaller step. No material defect was found during of the analysis of the rupture pattern. Unused available drills have been measured and meet drawing specifications. 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.
Patient Sequence No: 1, Text Type: N, H10
[66687962]
In this event it was reported that a calibration drill separated. Multiple unsuccessful attempts were made to obtain the patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2016-00084 |
| MDR Report Key | 6297233 |
| Date Received | 2017-02-02 |
| Date of Report | 2017-02-02 |
| Date Mfgr Received | 2016-06-30 |
| Date Added to Maude | 2017-02-02 |
| 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 | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY MAILLEFER |
| Manufacturer Street | CHEMIN DU VERGER 3 |
| Manufacturer City | BALLAIGUES, 1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CALIBRATION DRILL |
| Generic Name | DRILL, DENTAL, INTRAORAL |
| Product Code | DZA |
| Date Received | 2017-02-02 |
| Returned To Mfg | 2016-06-30 |
| Model Number | NA |
| Catalog Number | V040925000001 |
| Lot Number | 1150461 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY VDW GMBH |
| Manufacturer Address | BAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-02 |