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

Catalog Number 780044

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

This report summarizes 2 malfunction events where a midwest tradition handpiece would not hold burs.No injury resulted in any of the events.

Manufacturer Narrative

2 of 2 devices were returned for evaluation.Evaluation of 1 device found normal chuck wear and the turbine needed to be replaced.The device was repaired and returned to the customer.Evaluation of 1 device found a bandit cartridge was placed in the device, which is not compatible with our device.The device was repaired and returned to the customer.

• 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 Key: 15124597
• MDR Text Key: 302495385
• Report Number: 9614977-2022-00040
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2022

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 Catalogue Number: 780044
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2022
• Patient Sequence Number: 1