MAUDE Adverse Event Report: DENTSPLY VDW GMBH RECIPROC FILES 6X; FILE, PULP CANAL, ENDODONTIC

Catalog Number V040212025025

Device Problem Break (1069)

Patient Problem Apicectomy (2372)

Event Type  malfunction  

Manufacturer Narrative

Therefore, because this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it is reportable per 21 cfr part 803.The involved reciproc r25 8/10 25mm 025 is actually broken in the active part (fatigue).No material defect was found during analysis of the rupture pattern.Unused products have been evaluated according to our prescriptions and were found in compliance with specifications (measures, torque test).Nothing unusual to report was found during dhrs review (batches #(b)(4)).Root causes are not identified.This kind of event is tracked and we monitor the trend.

Event Description

In this event it was reported that a reciproc broke during use.There has been a root end surgery / apicoectomy.

• Brand Name: RECIPROC FILES 6X
• Type of Device: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 8438909
• MDR Text Key: 139420582
• Report Number: 9611053-2019-00052
• Device Sequence Number: 1
• Product Code: EKS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V040212025025
• Device Lot Number: 244816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1