MAUDE Adverse Event Report: A-DEC, INC. SYNEA 400 SERIES; HANDPIECE, AIR-POWERED, DENTAL

Model Number WG-99 LT

Device Problems Overheating of Device (1437); Component Missing (2306); Mechanical Jam (2983)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

On thursday, (b)(6) 2023, a patient presented to the dental clinic for routine procedure (dental fillings).During this procedure, a high-speed handpiece is used.This medical device was tested prior to use, per manufacturer requirements, and appeared to be functioning appropriately.Because the handpiece (drill) is anticipated to heat up with use, water is used as a coolant.As such, the testing performed prior to use includes verification that the burr is in and spins correctly, and that water comes out to validate the cooling process is working.Additionally, the end-user stated that the press-button was not believed to be inadvertently activated during the operation of the equipment, which would have been something that, if pressed, could cause the device to overheat.In about 7 seconds, the high-speed handpiece overheated and burned the patient's lip (area of injury ~1cm x 1cm).The patient was informed immediately and prescribed chlorhexidine rinse for 14 days.The manufacturer provided the following information, "[the handpiece] seized from what looks to be a lack of lubrication.There was no lubrication present in the handpiece when it was evaluated.There was no visible physical damage to warrant the bearing failure." of note, the malfunction of the device that occurred on 4/27 at the time of the burn was that it had overheated; there was no indication that it had seized during use on the patient.Based on the information provided by the manufacturer to biomed via email and brief phone call, the following determination was made: while damage to the handpiece was certainly sustained, it could not be determined whether the seizing could have led to it overheating.The repairs necessary on this device per the manufacturer's statement of a "complete overhaul" were the replacement of all drive gear assemblies, bearings, and water/air seals.

• Brand Name: SYNEA 400 SERIES
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): A-DEC, INC.; newberg OR 97132
• MDR Report Key: 17248236
• MDR Text Key: 318364338
• Report Number: MW5119063
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WG-99 LT
• Device Catalogue Number: 30023000
• Device Lot Number: 0.30195.000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White