MAUDE Adverse Event Report: DENTSPLY MAILLEFER GP PLUGGER; PLUGGER, ROOT CANAL, ENDODONTIC

Catalog Number A289S00100200

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

In this event, it was reported that a plugger broke during use; there is no indication that injury resulted and the broken piece remained attached to the instrument.

Manufacturer Narrative

While no serious injury resulted in this event, 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 possible 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.

Manufacturer Narrative

Returned plugger (active part #1) is actually broken into the swan neck with a long visible crack (the broken parts are however still attached together, there was no separation).No material defect was found during analysis of the rupture pattern.No unused device is available for evaluation.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: GP PLUGGER
• Type of Device: PLUGGER, ROOT CANAL, ENDODONTIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; ballaigues ; SZ
• Manufacturer Contact: helen lewis ; 221 w philadelphia st, ste 60; susquehanna commerce center w; york, PA 1740 ; 7178457511
• MDR Report Key: 4843790
• MDR Text Key: 5874426
• Report Number: 8031010-2015-00019
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• 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?: Yes
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• 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