MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH S-12; SURGICAL HANDPIECE 1:2

Model Number	30061000
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After inspection of the affected handpiece, no defect/error was identified in the device.
Event or Problem Description
The handpiece was used with copious saline irrigation (40%) attached to surgical handpiece irrigation input.Side of handpiece (not bur) overheated and burned patients's face/lip during decoronating crown of tooth #18.Handpiece overheated to high level caused 2nd degree burn to patient along vermillion border and onto skin of chin.Copious saline irrigation was utilized/attached to handpiece; however, overheating was a result of overheating/malfunction of the body of the han.

• Brand Name: S-12
• Common Device Name: SURGICAL HANDPIECE 1:2
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser strasse 53; buermoos, salzburg 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BUERMOOS GMBH; werner bader strasse 1; buermoos, salzburg 5111 ; AU 5111
• Manufacturer Contact: gerhard weidler ; werner bader strasse 1; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 24924982
• Report Number: 3003755849-2026-00001
• Device Sequence Number: 10275976
• Product Code: KMW
• UDI-Device Identifier: J021300610001
• UDI-Public: J021300610001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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
• Device Model Number: 30061000
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown