MAUDE Adverse Event Report: CONMED LARGO 6.5 X 38MM E9000 FLUTED LOW SPEED OPTIMUM BUR,ROUND,CARBIDE; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	E8165LSO
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
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 e8165lso, 6.5 x 38mm e9000 fluted low speed optimum bur,round, was being used during a tympanoplasty procedure on 13oct22 when it was reported, ¿broke 30 seconds into the case.(head of bur broke from shaft).¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned.Further assessment questions found that the device component fell into the patient and was retrieved with a hemostat.There was no report of delay to the procedure.The current status of the patient was listed as ¿patient at home recovering¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The returned used device, item e8165lso, found bur head detached from the shaft.Critical dimensions were inspected per print and could not find any discrepancies with machined bur.No defects were found through measurement or examination of the returned product.Evaluation shows that excessive force (load) was used during the procedure, and this device is technique dependent.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 13 complaints, regarding 14 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 0.00003.Per the instructions for use, the user is advised do not use burs for plunge cutting.Injury or damage may occur.Let the bur do the cutting.Excessive pressure is not needed.Ensure the bur is perpendicular with the cutting surface.Do not angle the cutting tool or attempt to force or saw with the bur into the bone.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories.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 e8165lso, 6.5 x 38mm e9000 fluted low speed optimum bur,round, was being used during a tympanoplasty procedure on (b)(6) 2022 when it was reported, ¿broke 30 seconds into the case.(head of bur broke from shaft).¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed as planned.Further assessment questions found that the device component fell into the patient and was retrieved with a hemostat.There was no report of delay to the procedure.The current status of the patient was listed as ¿patient at home recovering¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 6.5 X 38MM E9000 FLUTED LOW SPEED OPTIMUM BUR,ROUND,CARBIDE
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 15726174
• Report Number: 1017294-2022-00103
• Device Sequence Number: 14185611
• Product Code: GFF
• UDI-Device Identifier: 10845854010471
• UDI-Public: (01)10845854010471(17)270711(30)1(10)1254745
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: E8165LSO
• Device Catalogue Number: E8165LSO
• Device Lot Number: 1254745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic