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.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.Investigation results: summary: involved product that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1804085).No information was formally 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.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 start-x tip satelec insert 3 broke during use.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

Additional information received that there was no injury that occurred for this event.This is a follow up report for this information.Fda coding that was initially reported in the initial report for health effect- clinical code is being corrected from code 4580 to 4582.This is a follow up report to correct this code.Fda coding that was initially reported in the initial report for health effect- impact code is being corrected from code 4648 to 2199.This is a follow up report to correct this code.

• 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: 19030884
• MDR Text Key: 339235988
• Report Number: 8031010-2024-00028
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 04/23/2024

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: 03/25/2024
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1