MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL PRODUCT CODE EFB

Catalog Number 875101

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).11 of 12 devices were returned for evaluation.We are awaiting the return of 1 device.Evaluation of one device found it to be within specification.Evaluation of six devices found excessive wear due to a lack of proper maintenance.Evaluation of one device found excessive wear due to a lack of proper maintenance and lubrication.Evaluation of two devices found excessive wear due to a lack of proper maintenance and had debris build-up.Evaluation of one device found excessive wear due to a lack of proper maintenance and that device did heat up during evaluation.The device was repaired and returned to the customer.The ten devices did not heat up during evaluation.The devices were repaired and returned to the customers.

Event Description

This report summarizes 12 malfunction events where a midwest e mini 1:5 high speed contra angle attachment overheated.No injury resulted in any of the events.

• Brand Name: MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL PRODUCT CODE EFB
• 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: 16773042
• MDR Text Key: 313615807
• Report Number: 9614977-2023-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 12
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 875101
• Patient Sequence Number: 1