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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST TRADITION HANDPIECE; HANDPIECE, AIR-POWERED, DENTAL
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SIRONA DENTAL SYSTEMS GMBH MIDWEST TRADITION HANDPIECE; HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 790344
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional serial numbers included in this report: (b)(4).6 of 6 devices were returned for evaluation.Evaluation of 4 devices found normal chuck wear and the turbines needed to be replaced.The devices were repaired and returned to the customers.Evaluation of 1 device found chuck wear and lack of maintenance.The device was cleaned of debris and the turbines were replaced.The device was repaired and returned to the customer.Evaluation of 1 device found a non-dentsply sirona turbine (manufactured by bandit), which is an incompatible component.
 
Event Description
This report summarizes 6 malfunction events where a midwest tradition handpiece would not hold burs.No injury resulted in any of the events.
 
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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.
suite 60w
york, PA 17401
7178494593
MDR Report Key15639399
MDR Text Key304790896
Report Number9614977-2022-00070
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K131319
Number of Events Reported6
Summary Report (Y/N)Y
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 10/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number790344
Patient Sequence Number1
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