MAUDE Adverse Event Report: DENTSPLY MAILLEFER SENSEUS FLEXOFILE

Catalog Number A101202101000

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Event Description

In this event it was reported that two senseus flexofiles separated; outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

There has been a previous report received where this malfunction with a similar device 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 21 cfr part 803.This report is for the first device.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

The first involved file is actually bent at the tip (torque), the second involved file is rather untwisted in the active part (torque).No material defect was found during analysis of the damaged areas.The third involved file is unscathed.Unused product has been evaluated according to our prescriptions and was found in compliance with specifications (measures, torque test).Nothing unusual to report was found during dhr review.Root causes are not identified.This kind of event is tracked and we monitor the trend.

• Brand Name: SENSEUS FLEXOFILE
• Manufacturer (Section D): DENTSPLY MAILLEFER ; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; susquehanna commerce center w.; 221 w. philadelphia st., ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4910084
• MDR Text Key: 6834926
• Report Number: 8031010-2015-00027
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A101202101000
• Device Lot Number: 1191195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1