MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH W&H; SURGICAL HANDPIECE

Model Number	S-11
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a surgery (wisdom tooth) coronoradicular section with bulb bur on the 48 tooth included, a patient was deeply burned on the 3rd level (lower lip).Risk of permanent injury with aesthetic damage for the patient.Update on 06/02/2025: the surgeon who performed the surgery on the victim confirmed that the injury is reversible.A cosmetic surgery is necessary to remedy the injury and there is no doubt that it will completely scar.
Additional Manufacturer Narrative
During the analysis, it was found that the handpiece tip was no longer sufficiently attached to the bearing sleeve, which indicated poor gluing during manufacture.When the tip was loosened, the seal was no longer held in the correct position, became loose and damaged.This defect led to the increased temperature rise.

• Brand Name: W&H
• Common Device Name: SURGICAL HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: gerhard weidler ; werner bader strasse 1; buermoos, 5111 ; AU 5111
• MDR Report Key: 21457856
• Report Number: 3003755849-2025-00003
• Device Sequence Number: 12703531
• Product Code: KMW
• UDI-Device Identifier: J021300560001
• UDI-Public: J021300560001
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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: S-11
• Device Catalogue Number: 30056000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female