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

Catalog Number A066100000300

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 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 device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that start-x tip ems 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 for outcome of the event: all broken parts were retrieved from patient's mouth; no injury occurred.Summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused device is available for evaluation.Nothing unusual to report was found during dhr review (batch #1818239).We cannot rule on the compliance of the power settings selected by the customer compared to the ones recommended by maillefer which are exclusively given for ems generators.Root causes are not identified.We will track this kind of event and monitor the trend.Generally speaking, several other factors may contribute to breakage issue, such as usury, pressure or incorrect technique.All of these factors may affect the longevity of the tip.

• Brand Name: START-X TIP EMS 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: 18151447
• MDR Text Key: 329446342
• Report Number: 8031010-2023-00869
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 12/27/2023

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: A066100000300
• Device Lot Number: 1818239
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/07/2023
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1