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

Catalog Number 780344

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).35 of 35 devices were returned for evaluation.Evaluation of 21 devices found normal chuck wear and the turbine needed to be replaced in each device.The devices were repaired and returned to the customers.Evaluation of 13 devices found chuck wear and lack of maintenance.The devices were cleaned of debris and the turbines were replaced.The devices were repaired and returned to the customers.Evaluation of 1 device found chuck wear due to damage / deformation.The device was repaired and returned to the customer.

Event Description

This report summarizes 35 malfunction events.This report summarizes 35 malfunction events where midwest tradition handpieces would not hold dental burs.In 34 events, there were no injuries.In one event, a patient swallowed a bur, however, there was no injury or intervention required.

• Brand Name: MIDWEST TRADITION LEVER CHUCK - FIXED BACKEND
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 9262994
• MDR Text Key: 184697183
• Report Number: 9614977-2019-00136
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 35
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/31/2019

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: No Information
• Device Catalogue Number: 780344
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1