MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL START-X TIP SATELEC INSERT 3; SCALER, ULTRASONIC

Catalog Number A066000000300

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.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.

Event Description

In this event it is reported that start-x tip satelec insert 3 tip broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

Additional information received: the investigation results for this complaint are.1.They used woodpecker device with slow speed.2.They implemented endo treatment for upper first molar and opened central canal, always using rubber-dam.Patient was not injured during the procedure.The instrument just cracked into 2 pieces with no flying away but remaining into cavity and was able to remove with tweezers.3.Patient did not need any additional treatment because of the incident.Investigation summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1804085).No information was given regarding technique, we cannot rule on its compliance with maillefer's recommendations.Root causes are not identified.We will track this kind of event and monitor the trend.With additional information received correcting previously submitted codes: 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.This is a follow up report to correct these corrected codes.

• Brand Name: START-X TIP SATELEC INSERT 3
• Type of Device: SCALER, ULTRASONIC
• 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: 18562287
• MDR Text Key: 333455973
• Report Number: 8031010-2024-00001
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: EN
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A066000000300
• Device Lot Number: 1804085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/11/2024
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1