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  

Event Description

It was reported that a start-x tip satelec insert 3 broke.No patient injury was reported.No perforation, no other surgical treatment needed after the event.

Manufacturer Narrative

Start-x tip broke during use; no injury resulted.While no serious injury resulted in this event, there has been a previous report received with a similar device 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 small piece was thrown away by the customer.The broken product will be returned.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

Returned start-x tip satelec insert 3 is actually broken in the active part.No material defect was found during analysis of the rupture pattern.No unused device is available for evaluation.Nothing unusual to report was found during dhr review (batch #1715236).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.

• 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: 12954023
• MDR Text Key: 283391444
• Report Number: 8031010-2021-00375
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/24/2022

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: 1715236
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/22/2021
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1