BEUTELROCK REAMER V010944018003

MAUDE Adverse Event Report

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 V010944018003 manufactured by Dentsply Maillefer.

Event Text Entries

[46209113] 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


[46209114] It was reported that a beutelrock reamer broke during treatment; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


[50650191] 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


MAUDE Entry Details

Report Number9611053-2016-00021
MDR Report Key5684275
Date Received2016-05-27
Date of Report2016-04-28
Date Mfgr Received2016-06-17
Date Added to Maude2016-05-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. HELEN LEWIS
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494229
Manufacturer G1DENTSPLY MAILLEFER
Manufacturer StreetCHEMIN DU VERGER 3
Manufacturer CityBALLAIGUES, 1338
Manufacturer CountrySZ
Manufacturer Postal Code1338
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBEUTELROCK REAMER
Generic NameREAMER, PULP CANAL, ENDODONTIC
Product CodeEKP
Date Received2016-05-27
Returned To Mfg2016-04-28
Model NumberNA
Catalog NumberV010944018003
Lot Number113170
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY MAILLEFER
Manufacturer AddressCHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338


Patients

Patient NumberTreatmentOutcomeDate
10 2016-05-27

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