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

Catalog Number 790344

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

2 of 2 devices were returned for evaluation.Evaluation of two devices found excessive wear, due to a lack of proper maintenance.A friction problem was identified from pressure on the cap.The devices did not heat up, during evaluation.The devices were repaired and returned to the customer.

Event Description

This report summarizes 2 malfunction events.Where a midwest tradition handpiece overheated.2 events resulted in no injury.

• 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 19181039
• MDR Text Key: 341791307
• Report Number: 9614977-2024-00009
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: E2767903440
• UDI-Public: E2767903440
• 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: 04/25/2024

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: 790344
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Patient Sequence Number: 1