MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PROTAPER GOLD S2 21MM STER; FILE, PULP CANAL, ENDODONTIC

Catalog Number A0410221G0203

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that protaper gold s2 21mm ster file broke.Request for product return and further information is requested.

Manufacturer Narrative

Instrument locally bent at 2mm/75°.Flutes with rewinding on 2.0-3.5mm from the tip.Cutting edges with wear.Cutting edges with cracks without step.Shaft with wear of the depth groove.Handle without damage.Flat breaking pattern perimeter, with perpendicular surface without steps following the grinding grooves at 2mm from the tip.Rotational marks of contact not visible.Material without visible defect.Ruptured instrument under mix conditions: torque, fatigue and then rupture under small torque (modeft1), while pulling out of a root canal curved portion.

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 S2 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: 12917105
• MDR Text Key: 283084285
• Report Number: 8031010-2021-00371
• 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: 01/11/2022

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: A0410221G0203
• Device Lot Number: 1683005
• 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