MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH ELCOMED SURGICAL HANDPIECE / DRILL; HANDPIECE, ROTARY BONE CUTTING

Model Number S-11

Device Problems Vibration (1674); Output Problem (3005); Temperature Problem (3022)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/24/2023

Event Type  Injury  

Event Description

Pt 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 4-0 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.Ref report: mw5116403.

• Brand Name: ELCOMED SURGICAL HANDPIECE / DRILL
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH
• MDR Report Key: 16700278
• MDR Text Key: 312874844
• Report Number: MW5116402
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S-11
• Device Catalogue Number: 3005600
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSOLE
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Hispanic