MAUDE Adverse Event Report: CONMED LARGO HALL ORALMAX ELITE HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO7000DE

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

Event Description

The sales representative reported on behalf of the customer, that the (b)(4), hall oralmax elite high speed drill was being used on approximately 01apr24 date when it was reported ¿the brand-new handpieces were overheating.Dr.Calls me and is saying it is happening again and burnt a patient's lip.Unknown which one or if both burned the patient.¿.Further assessment was attempted, and a good faith effort was completed with no additional information found.There was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported injury due to an unknown degree of burn.

Manufacturer Narrative

He device was not overdue for preventative maintenance.The device was found to have a defective cast stator.The device also needed new etching.The device was repaired, tested, and met all specifications.The root cause cannot be determined, however, based upon the evaluation, and an adverse event review meeting, the likely cause of this event was that the bur guard was not kept properly cleaned.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed and no relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding 4 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised to continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.Bur guards should always be checked before use.To reduce the risk of injury, prior to surgery, spin the bur guard on a bur.If the bur guard spins freely, the bearing is still good.Otherwise, the bur guard must be sent for repair immediately.Do not use.Overheating can occur if bur guard bearings are worn or not kept clean.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Update: further assessment information found that the patient was diagnosed with a second degree burn and it was treated with bacitracin.The current status of the patient was reported as "well healed.".The sales representative reported on behalf of the customer, that the pro7000de, hall oralmax elite high speed drill was being used on approximately (b)(6) 2024 date when it was reported ¿the brand-new handpieces were overheating.Dr.Calls me and is saying it is happening again and burnt a patient's lip.Unknown which one or if both burned the patient.¿.Further assessment was attempted, and a good faith effort was completed with no additional information found.There was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported injury due to an unknown degree of burn.

• Brand Name: HALL ORALMAX ELITE HIGH SPEED DRILL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19152927
• MDR Text Key: 340716005
• Report Number: 1017294-2024-00042
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2024

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 Operator: Health Professional
• Device Catalogue Number: PRO7000DE
• Device Lot Number: 20230106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic