MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER GOLD S1 21MM STER; FILE, PULP CANAL, ENDODONTIC

Catalog Number A0410221G0103

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that a protaper gold s1 file broke.Additional information was requested for product return and further information.

Manufacturer Narrative

There has been a previous report received 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 has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

Multiple unsuccessful attempts were made to obtain the patient outcome.

Manufacturer Narrative

The three returned protaper gold shaping files s1 21mm are actually broken in the active part (1x fatigue), or at the tip of the active part (1x fatigue; 1x mixed conditions torque + fatigue).No material defect was found during analysis of the rupture patterns.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1683007).Root causes are not identified.We will track this kind of event and monitor the trend.

Event Description

Additional information was received indicating that the broken portion of the file was removed from the patient¿s tooth.

• Brand Name: PROTAPER GOLD S1 21MM 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: 12916865
• MDR Text Key: 283083168
• Report Number: 8031010-2021-00370
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A0410221G0103
• Device Lot Number: 1683007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/10/2021
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1