MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL PLUGGER 1-2; PLUGGER, ROOT CANAL, ENDODONTIC

Catalog Number A289S00100200

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

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 was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.No product and no lot# available.No investigation or dhr review can be done.Root causes are not determined.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

Event Description

In this event it is reported that plugger 1-2 broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

Additional information received : no injury occurred.All brokent parts were removed from patient's mouth, no further medical/surgical treatment necessary.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code -4580.Health effect - impact code - 4648.The correct codes for this complaint are: health effect - clinical code - 4582.Health effect - impact code - 2199.

• Brand Name: PLUGGER 1-2
• Type of Device: PLUGGER, ROOT 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: 16334295
• MDR Text Key: 309162791
• Report Number: 8031010-2023-00741
• Device Sequence Number: 1
• Product Code: EKR
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A289S00100200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/26/2023
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1