MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS S-11 SURGICAL HANDPIECE; S-11 SURGICAL HANDPIECE 1:1

Model Number	S-11
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We were unable to obtain any further information about this event.Therefore, no causal research could be conducted and no corresponding conclusions could be drawn.
Event or Problem Description
Patient was having removal of her wisdom teeth, which requires removal of bone and sectioning of teeth with a high-speed rotary instrument.We use a surgical straight handpiece with a motor that runs at standard 50,000 rpm (mfr: w&h elcomed).A 702 carbide bur was used with copious normal saline irrigation.I always use my fingers to hold the lip / cheek out to not only get more light into the field, but also to avoid trauma from the bur.A few mins after sectioning tooth #47, my assistant noticed a deep (3rd degree) burn to the left lip commissure, evidently as a result of the shaft of the handpiece having contact with tissues while in use.This is expected.We use surgical handpieces everyday, but i have never encountered a burn like this before.I did not feel any heat generated by the handpiece itself, and we didn't actually even see the burn until a min or 2 later, almost as if it was a delayed reaction to whatever heat or vibration was being generated by the handpiece.To clarity it was not the bur, but rather the shaft of the handpiece vs, motor itself.I couldn't tell which was responsible.The burn was full thickness into muscle.Though there was not even any bleeding from the wound.No signs of trauma were identified intraorally.The site of burn was approx 5x5mm full-thickness through lip commissure on left, from mucosa out to the skin.It was cleansed, inspected, and closed with deep sutures 4-o vicryl and 5-0 fast absorbing gut on the skin, taking care to align the vermillion border.Dressing with sterri strips was applied.Pt was notified of incident and instructed to return in 1wk to evaluate, remove dressing and possibly sutures.She did not return for her follow-up.

• Brand Name: S-11 SURGICAL HANDPIECE
• Common Device Name: S-11 SURGICAL HANDPIECE 1:1
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BUERMOOS; ignaz-glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: johann scharl ; ignaz glaser strasse 53; buermoos, 5111 ; AU 5111
• MDR Report Key: 17212302
• Report Number: 3003755849-2023-00001
• Device Sequence Number: 15050707
• Product Code: KMW
• UDI-Device Identifier: J021300560001
• UDI-Public: J021300560001
• Combination Product (Y/N): N
• 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: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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: 300056000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MAUDE REPORT MW5116402
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown