MAUDE Adverse Event Report: DENTSPLY MAILLEFER GUTTA-PERCHA PLUGGER; PLUGGER, ROOT CANAL, ENDODONTIC

Catalog Number A289S00100200

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

However, since there has been a previous report received with the same product where this malfunction resulted in a serious injury 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

In this event it was reported that a machtou plugger separated.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Additional information was received indicating that no patient was involved as the plugger broke during sterilization.Returned plugger has one of tip (#1) which is actually broken in the second depth ring.No material defect was found during analysis of the rupture pattern.The batch number is unknown, dhr cannot be reviewed.Root causes are not identified.This kind of event is tracked and we monitor the trend.

• Brand Name: GUTTA-PERCHA PLUGGER
• Type of Device: PLUGGER, ROOT CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178457551
• MDR Report Key: 6408969
• MDR Text Key: 70315102
• Report Number: 8031010-2017-00006
• Device Sequence Number: 1
• Product Code: EKR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A289S00100200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1