MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MAXIMA ELITE; HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL

Catalog Number 6361849

Device Problems Overheating of Device (1437); Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur.As such, this event meets the definition of a reportable event per 21 cfr part 803.The device was investigated by the importer.The importer's investigation observed that the back cap had a dark wear mark in the center.This indicates that the actuator met the inside of the back cap at some point during operation of the handpiece.This causes friction which heats up the cap causing discoloration.Upon testing the handpiece, it is determined that the actuator does not make contact with the cap unless the cap is depressed.The handpiece was tested for it's speed, air flow, water flow, cooling, noise, vibration, and heat brought on by amperage draw, all testing parameters and specifications were met.It was determined that during the procedure the handpiece was used as a cheek retractor which resulted in the depression of the cap into the chuck actuator while the handpiece was in use, causing the drag and friction to heat up the cap and burn the patient.Reference importer report # (b)(4).

Event Description

An assistant at the office, health professional, reports that when prepping buccal of tooth#18 for a filling procedure, the handpiece by the back button that is pressed to engage the bur became hot and burned the patient's cheek.The patient was a 41 year old female patient.The patient was referred to an oral surgeon and was also given antibiotics by the office fearing the area would get infected, not specifying what.The patient also coincidentally also got covid at the same time.Since the date of incident((b)(6) 2022), the husband said that his wife has gotten better.

• Brand Name: MAXIMA ELITE
• Type of Device: HANDPIECE, BELT AND/OR GEAR DRIVEN, 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: 15457338
• MDR Text Key: 300272028
• Report Number: 9614977-2022-00056
• Device Sequence Number: 1
• Product Code: EFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6361849
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female