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

Catalog Number 875205

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This report summarizes 47 malfunction events where a midwest e plus handpiece overheated.In 8 events, patients had a minor burn and did not require intervention.In 28 events, no injury resulted.In 11 events, the outcome is unknown despite follow-up.

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).47 of 47 devices were returned for evaluation.Evaluation of 1 device found it to be within specification.Evaluation of 4 devices found excessive wear due to a lack of proper maintenance and lubrication.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 13 devices found excessive wear due to a lack of proper maintenance.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of 3 devices found excessive wear due to a lack of proper maintenance.The devices did heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of 22 devices found excessive wear due to a lack of proper maintenance.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 4 devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The devices did heat up during evaluation.The devices were repaired and returned to the customers.

• Brand Name: MIDWEST E PLUS 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: 13401397
• MDR Text Key: 289336392
• Report Number: 9614977-2021-00084
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 47
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 875205
• Patient Sequence Number: 1