MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST TRADITION HANDPIECE; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 780044L

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

1 of 1 devices were returned for evaluation.Evaluation of 1 device found chuck wear and lack of maintenance.The device were cleaned of debris and the turbines were replaced.The device were repaired and returned to the customer.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.Dentsply sirona has not received any reports of death or serious injury for a bur or file walkout malfunction since february 2020.(b)(4).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 summary 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

This report summarizes 1 malfunction events where a midwest tradition handpiece would not hold burs.No injury resulted.

• Brand Name: MIDWEST TRADITION HANDPIECE
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 16789749
• MDR Text Key: 313764853
• Report Number: 9614977-2023-00028
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2023

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?: No
• Device Catalogue Number: 780044L
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2023
• Patient Sequence Number: 1