PROTAPER GOLD F3 25MM STER A0411225G0303

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-07 for PROTAPER GOLD F3 25MM STER A0411225G0303 manufactured by Dentsply Maillefer.

Event Text Entries

[178174621] Therefore, because this event resulted in medical/surgical intervention to preclude permanent impairment/damage of a body structure, it is reportable per 21 cfr part 803. Returned protaper gold finishing file f3 25mm is actually broken at the base of the active part (fatigue). No material defect was found during analysis of the rupture pattern. We however note that the cutting edges are damaged (wear off and many nicks can be observed). No unused file is available for evaluation. The batch number is unknown, dhr cannot be reviewed. Root causes are not identified. We will track this kind of event and monitor the trend.
Patient Sequence No: 1, Text Type: N, H10


[178174622] In this event it was reported that a protaper file broke during use. The file was retrieved. An apicoectomy was performed (root tip resection).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031010-2020-00007
MDR Report Key9682103
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-07
Date of Report2020-02-07
Date of Event2019-12-19
Date Mfgr Received2020-01-09
Date Added to Maude2020-02-07
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 ContactMR. KARL NITTINGER
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 NamePROTAPER GOLD F3 25MM STER
Generic NameFILE, PULP CANAL, ENDODONTIC
Product CodeEKS
Date Received2020-02-07
Returned To Mfg2020-01-13
Model NumberNA
Catalog NumberA0411225G0303
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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
101. Required No Informationntervention 2020-02-07

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