MAUDE Adverse Event Report: DENTSPLY MAILLEFER PROTAPER GOLD F3 25MM STER; FILE, PULP CANAL, ENDODONTIC

Catalog Number A0411225G0303

Device Problem Break (1069)

Patient Problem Apicectomy (2372)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

In this event it was reported that a protaper file broke during use.The file was retrieved.An apicoectomy was performed (root tip resection).

• Brand Name: PROTAPER GOLD F3 25MM STER
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 9682103
• MDR Text Key: 178174621
• Report Number: 8031010-2020-00007
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A0411225G0303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention