MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for BEUTELROCK REAMER V010944018002 manufactured by Dentsply Maillefer.
[46204725]
There has been a previous report received for 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. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available. Please note that while this product is not sold in the us, it is considered similar to products that are when taking into account composition and indications for use.
Patient Sequence No: 1, Text Type: N, H10
[46204726]
It was reported that a beutelrock reamer broke during treatment; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
[50649737]
One broken instrument and one unused instrument was received for evaluation. No material defect was found with the unused file. Root causes are not identified. We will track this kind of event and monitor the trend. The files are constructed with a predetermined breaking point, so that if the user used excessive force than the files break only on this area.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611053-2016-00020 |
| MDR Report Key | 5684273 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-04-28 |
| Date Mfgr Received | 2016-06-17 |
| Date Added to Maude | 2016-05-27 |
| 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 | 3 |
| Brand Name | BEUTELROCK REAMER |
| Generic Name | REAMER, PULP CANAL, ENDODONTIC |
| Product Code | EKP |
| Date Received | 2016-05-27 |
| Returned To Mfg | 2016-04-28 |
| Model Number | NA |
| Catalog Number | V010944018002 |
| Lot Number | 115983 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY MAILLEFER |
| Manufacturer Address | CHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-27 |