MAUDE Adverse Event Report: CONMED LARGO BUR GUARD, LONG; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number	1375-011
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/24/2022
Type of Reportable Event	Serious Injury
Additional 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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 00137501100, bur guard, long was being used on (b)(6) 2022 during an oral surgery burring and the device ¿heated up and burnt patients cheek¿.The procedure was completed with a different hand piece and bur guard and there was a 30 minute delay to the procedure.The patient status was reported as ¿good¿.Further assessment found, it is not known if treatment was given or what degree of burn was received.This report is being raised on the basis of injury due to unknown degree of burn.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 00137501100, bur guard, long was being used on 24jan22 during an oral surgery burring and the device ¿heated up and burnt patients cheek ¿.The procedure was completed with a different hand piece and bur guard and there was a 30 minute delay to the procedure.The patient status was reported as ¿good¿.Further assessment found, it is not known if treatment was given or what degree of burn was received.This report is being raised on the basis of injury due to unknown degree of burn.
Additional Manufacturer Narrative
Reported event of device burning patient is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 1 report, regarding 1 device, for this device family and failure mode.During this same time frame 10,272 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 0.0001.Per the instructions for use, the user is advised the following: inspect for dull and/or chipped cutting surfaces on the bur.Use of dull burs may cause heat buildup, add time to the procedure and/or cause thermal damage.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: BUR GUARD, LONG
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13542146
• Report Number: 1017294-2022-00023
• Device Sequence Number: 14400008
• Product Code: GET
• UDI-Device Identifier: 10845854018996
• UDI-Public: (01)10845854018996(11)210922(10)1195824
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 1375-011
• Device Catalogue Number: 00137501100
• Device Lot Number: 1195824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic