MAUDE Adverse Event Report: CONMED CORPORATION HALL ORALMAX ELITE HIGH SPEED DRILL

Catalog Number PRO7000DE

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 08/16/2018

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.

Event Description

The customer reported that the pro7000de, hall oralmax drill, allegedly " became instantly hot and burnt the palm and index finger of the assistant.The unit will be sent in for repair." further assessment cannot be performed due to physicians office being closed.This report is being raised on the basis of a reported injury.

Manufacturer Narrative

Visual examination of the device and device testing found the hand piece running fine with a different burgard.The temperature by the collet was found at 94 degrees; allowable temperature after 3-minute run time is 110 degrees fahrenheit.Additionally, the collet nose bond failed between the collet and nose.Parts were replaced, the device was repaired, the preventative maintenance was done, and the device was tested.A device history review found no anomalies that would contribute to this issue.The service history was reviewed, and no relationship to this complaint was found.A two-year review of device history revealed there has been 2 complaints, regarding 2 devices, for this device family and failure mode.During the same time frame 2,812 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.0007 per the instructions for use, the user is advised the following; - continually check the handpiece for overheating and if sensed immediately discontinue use and return equipment for service.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HALL ORALMAX ELITE HIGH SPEED DRILL
• Type of Device: HIGH SPEED DRILL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 7865257
• MDR Text Key: 119865511
• Report Number: 1017294-2018-00147
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PRO7000DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other