MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL HEAT-CARRIER PLUGGER 2-3; PLUGGER, ROOT CANAL, ENDODONTIC

Catalog Number A281S00200300

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

In this event it is reported that a heat-carrier plugger 2-3 broke during use.Outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

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 has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Additional information received: we received the following information regarding this complaint no patient was injured.The broken parts were not in the patient's mouth or were removed from there.No further treatment, either medical or surgical, was required.The instrument was used approx.1x daily before the incident.Investigation summary: the returned heat-carrier plugger 2-3 is not broken, but one of the active part (size 3) got detached from the handle and was not returned.We can see that the aluminum core of the handle began to oxidize at the place where the active part size 3 was clamped.The batch number is unknown, dhr cannot be reviewed.Reprocessing procedure followed by the customer being unknown, we cannot rule on its compliance with maillefer recommendations.Root causes of the oxidization are not identified.For information, hand instruments (like heat-carrier pluggers) can be degraded by peroxid hydrogen (h2o2) solutions and components made of aluminum can be degraded in presence of caustic soda solutions with mercury salt.

• Brand Name: HEAT-CARRIER PLUGGER 2-3
• 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: 15751354
• MDR Text Key: 307770320
• Report Number: 8031010-2022-00683
• Device Sequence Number: 1
• Product Code: EKR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A281S00200300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/27/2022
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1