MAUDE Adverse Event Report: CONMED CORPORATION BUR GUARD, MEDIUM; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number	1375-012
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was confirmed.The returned used device, item 00137501200, was inspected per the service and repair procedure and found inner race bearing out of position due to broken bearing.As a result, the bur could not be inserted into the bur guard.Condition of the returned device prevents further testing; however, this type of failure would potentially cause the temperature to increase greatly.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 were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this device and lot number combination and failure mode.A two-year review of complaint history revealed there has been a total of 34 complaints, regarding (b)(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).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu the user is also advised that overheating might occur if bearings are worn or are not kept clean.If overheating occurs, discontinue use and return for service.Before each use, be sure that burs are completely seated and locked in the instrument.If the instrument is activated without the bur completely seated and locked, the bur may be thrown from the instrument with great force.Also, unless the bur is completely locked into place, severe overheating may occur.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
On behalf of the customer the conmed representative reported issues with the hall oralmax elite high speed drill, item # pro7000de, serial (b)(4) and the bur guard, medium, item # 00137501200, lot# 983015 that occurred during a molar extraction on (b)(6) 2019.It was reported that "during molar extraction on (b)(6) 2019, the unit became very hot and burned a patient's lip.Patient lip blistered." additional information obtained indicates that the drill & bur guard had been in use for 15-20 minutes.The doctor sectioned and removed tooth #17 with no drill issues and was starting the removal of #32 when the issue occurred.The doctor was sectioning tooth #32 to remove when the drill overheated causing an abrasion to patient's lower right lip adjacent to premolar area.A 5mm diameter blister was noted.No suture was needed, there was no additional medical intervention and the patient's lip / burn was treated with a thin layer of vaseline.The patient is reported to be well at this time and has not returned for treatment.The procedure was successfully completed using another hall drill with no reported delay.The bur guard, medium, item # 00137501200 lot#983015 will be reported on as basis of patient injury (lip burn).The hall oralmax elite high speed drill item # pro7000de is being listed as a concomitant device as the drill itself cannot cause the burn as reported.

• Brand Name: BUR GUARD, MEDIUM
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 8527700
• Report Number: 1017294-2019-00047
• Device Sequence Number: 1920101
• Product Code: GET
• UDI-Device Identifier: 10845854012338
• UDI-Public: (01)10845854012338(11)181206(10)983015
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: 1375-012
• Device Catalogue Number: 00137501200
• Device Lot Number: 983015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HALL ORALMAX ELITE HIGH SPEED DRILL USED (B)(6) 2019
• Outcome Attributed to Adverse Event: Other