MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER GOLD S1 25MM STER; FILE, PULP CANAL, ENDODONTIC

Catalog Number A0410225G0103

Device Problem Break (1069)

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

Event Date 09/20/2021

Event Type  malfunction  

Event Description

It was reported that protaper gold s1 25mm ster files broke.Request for product return and further information 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 results are not available 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.

Manufacturer Narrative

Two protaper gold shaping files s1 25mm in loose were returned.One of the files is actually broken at the tip of the active part (fatigue).The second file is only bent at the tip of the active part.No material defect was found during analysis of the rupture pattern or damaged area.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1670130).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 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: 12929246
• MDR Text Key: 283242531
• Report Number: 8031010-2021-00372
• 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
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A0410225G0103
• Device Lot Number: 1670130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/15/2021
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1