MAUDE Adverse Event Report: DENTSPLY MAILLEFER START-X TIP; SCALER, ULTRASONIC

Catalog Number A066100000300

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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.Involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused product is available for evaluation.Nothing unusual to report was found during dhr review (batch #1655127).Customer stated having used the device wih a ems scaler set on power 3.According dfu, the power of the ultrasonic generator should be adjusted between 4 and 7.Customer settings are below recommendations.The root causes of the breakage are not definitely identified notably because the involved product is not available for analysis, but the generator setting may have favored a premature breakage.We will track this kind of event and monitor the trend.

Event Description

In this event it was reported that a start-x tip broke during use; no injury resulted.The broken parts have not been retrieved from the patient's mouth.

Manufacturer Narrative

X-smart head cap: bad maintenance (user).The file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.X-smart cartridge: various mechanical problem.I note that the cartridge is blocked.X-smart neck: various mechanical problem.Ball bearing of the neck is defective.It is not possible to be determined the root cause with certainty.The root cause is either a mechanical problem or a bad maintenance of user.Replaced 1 x x cartridge h1004c5210150, 1 x x neck h1004c5470220 and 1 x x head cap h1004c5210500.

Manufacturer Narrative

Additional information was received indicating that there was no injury.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 #1655127).Customer stated having used the device with a ems scaler set on power 3.According dfu, the power of the ultrasonic generator should be adjusted between 4 and 7.Customer settings are below recommendations.The root causes of the breakage are not definitely identified notably because the involved product is not available for analysis, but the generator setting may have favored a premature breakage.We will track this kind of event and monitor the trend.

• Brand Name: START-X TIP
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 12257259
• MDR Text Key: 264472277
• Report Number: 8031010-2021-00155
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2021

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 Operator: Health Professional
• Device Catalogue Number: A066100000300
• Device Lot Number: 1655127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/05/2021; 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1