MAUDE Adverse Event Report: W&H DENTALWERK BÜRMOOS GMBH HENRY SCHEIN; HANDPIECE

Model Number	MAXIMA ELITE 2 CONTRA ANGLE
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After evaluation of the affected handpiece, no defects could be detected.
Event or Problem Description
Two female patients were burned from the maxima elite 2 contra angle on two different occasions.One time was on (b)(6) 2024 while the other was on (b)(6) 2024.One patient is 43 years old while the other is 67 years old.It is not clear which had the burn where but one was on the lip while the other was on the buccal muscosa.The type of burn was a large ulcer.Vitamin e was placed on the area for the burn and no further treatment needed.It was the head part that got hot.One patient is doing fine as of today while the other they have not seen since.Additional correspondence from the doctor was received on (b)(6) 2024: it was stated that both a patient and staff member received a burn from the handpiece is this correct? no, 2 patients were burned.We were also made aware that it was a male and female.Which was the patient and which was the staff member? no, 2 female patients.Could you share the age of both the patient and staff member? 43 years old and 67 years old.Where was the burn received on each? one on the lip and the other on the buccal mucosa.What type of burn was received? it was a large ulcer.What was done to treat the burn received? vitamin e was placed.What part of the contra angle got hot? the head of the contra angle.How are both people affected doing as of today? we have not seen one since, the other is doing fine.Was there any medical treatment necessary? vitamin e ointment was placed, no further treatment needed.When did this happen, do you have a specific date when? on (b)(6) 2024.

• Brand Name: HENRY SCHEIN
• Common Device Name: HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BÜRMOOS GMBH; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: gerhard weidler ; werner bader strasse 1; buermoos, 5111 ; AU 5111
• MDR Report Key: 21270988
• Report Number: 3003755849-2025-00001
• Device Sequence Number: 8071127
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: (01)00304040153857
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAXIMA ELITE 2 CONTRA ANGLE
• Device Catalogue Number: 570-2660 (W&H: 30431000)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3007007357-2024-00034
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female