MAUDE Adverse Event Report: DENTSPLY MAILLEFER PROULTRA ENDO TIP #5; SCALER, ULTRASONIC

Catalog Number A062000000500

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Customer returned one broken a062000000500.Visual testing of instrument performed using microscope.No defects or markings were noted on instrument.The customer indicates the tip broke without touching the tooth.Complaint does not indicate what power setting was being used at time of breakage.Recommended setting for the endo 5 is minimum power setting of 1 and a maximum setting of 4.Several factors may contribute to breakage of tips, such as number of uses, intensity, and pressure.All of these may affect the longevity of the tip.It is recommended that the tip be at treatment site before engaging power.Also, these tips should be used with water.Root cause of breakage cannot be determined.

Event Description

In this event it was reported that a pro ultra endo tip zircon 5 broke during use; no injury resulted.

• Brand Name: PROULTRA ENDO TIP #5
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• Manufacturer (Section G): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7127801
• MDR Text Key: 95748401
• Report Number: 8031010-2017-00136
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K960889
• 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
• Report Date: 12/18/2017

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: A062000000500
• Device Lot Number: 0000119078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR