MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER GOLD ASSORT SX/F3 25MM STER; FILE, PULP CANAL, ENDODONTIC

Catalog Number A0409225G0103

Device Problems Break (1069); Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

In this event it has been reported that protaper gold assort sx/f3 25mm fractured during the first use, part of the file remained inside the patient's tooth canal.A request for further information and product return has been made.

Manufacturer Narrative

As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Event Description

Additional information was received indicating that the broken part will not be retrieved and will be incorporated into the filling.

Manufacturer Narrative

We received from the customer a unused protaper gold shaping file s2 25mm, a unused protaper gold finishing file f1 25mm, and two protaper gold finishing files f2 25mm in loose without damage.The involved protaper gold shaping file sx 19mm and protaper gold shaping file s1 25mm which broke during use were not returned and cannot be analyzed.No unused ptgsx or ptgs1 file is available for evaluation.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.

• Brand Name: PROTAPER GOLD ASSORT SX/F3 25MM STER
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 13544437
• MDR Text Key: 288475303
• Report Number: 8031010-2022-00450
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A0409225G0103
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/02/2022
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1