MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART PLUS; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Catalog Number A103200000000

Device Problem Detachment of Device or Device Component (2907)

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 a x-smart plus won't hold files.The outcome of this event is unknown as of this mdr and further information requested.

Manufacturer Narrative

Dentsply sirona has not received any reports of death or serious injury for a bur or file walkout malfunction since february 2020.Dentsply sirona has gathered historical complaint data that indicates the incidence of the bur or file walkout malfunction of our dental handpieces has a complaint rate of (b)(4)%, and a serious injury rate of (b)(4)% since the first injury in 1997.Thus, the probability of serious injury as a result of this malfunction is truly remote and therefore not likely.Therefore, dentsply sirona will cease malfunction reporting for bur or file walkout events with our dental handpieces, with this being our final malfunction individual report.Recurrence of a serious injury or death for this malfunction will trigger the resumption of mandatory reporting, per 21cfr part 803.50.

Event Description

Further information received indicating that no injury resulted.

Manufacturer Narrative

Additional information received that there was no injury.Investigation results: received = 1x x-smart plus cartridge h1033c1051015.X-smart plus cartridge sav various mechanical problem the rotation of the file is difficult because the ball bearing is damaged.Replaced 1x xp cartridge h1033c1051015.

• Brand Name: X-SMART PLUS
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
• 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: 16673643
• MDR Text Key: 312650304
• Report Number: 8031010-2023-00780
• Device Sequence Number: 1
• Product Code: EGS
• 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,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A103200000000
• Device Lot Number: 01764319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/31/2023
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1