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

Catalog Number 875101

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).12 of 12 devices were returned for evaluation.Evaluation of 10 devices found excessive wear due to a lack of proper maintenance.One of the devices had debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of 1 device found excessive wear due to a lack of proper maintenance and lubrication.The device did not heat up during evaluation.The device was repaired and returned to the customer.Evaluation of 1 device found excessive wear due to a lack of proper maintenance and lubrication.The device did heat up during evaluation.The device was repaired and returned to the customer.

Event Description

This report summarizes 12 malfunction events where a midwest e mini 1:5 high speed contra angle attachment overheated.Two patients experienced minor burns, no intervention was required.There was no injury in 10 of the events.

• Brand Name: MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• 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: 15628687
• MDR Text Key: 306992527
• Report Number: 9614977-2022-00060
• 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: 10/18/2022

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: 875101
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2022
• Patient Sequence Number: 1