MAUDE Adverse Event Report: CONMED LARGO 5 X 30MM E9000 FLUTED LOW SPEED OPTIMUM BUR, ROUND, CARBIDE; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	E8050LSO
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text: device not yet received.
Event or Problem Description
The customer reported that the device, e8050lso, 5 x 30mm e9000 fluted low speed optimum bur, round, was being used during a cochlear device implantation left ear procedure on (b)(6) 2023 when it was reported, ¿head of bur "fell off".The fluted round head of the bur bit sheared off during use.It was retrieved.¿ there was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the device, e8050lso, 5 x 30mm e9000 fluted low speed optimum bur, round, was being used during a cochlear device implantation left ear procedure on (b)(6) 23 when it was reported, ¿head of bur "fell off".The fluted round head of the bur bit sheared off during use.It was retrieved.¿ there was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Evaluation of the returned used device found the bur head detached from the shaft.Detached carbide bur head was returned for the evaluation and is approximately 0.192 of the inches.It is suspected that excessive force (load) was used during procedure.This is technique dependent device and the most likely cause of this suspected failure is user related.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 15 complaints, regarding 17 devices, for this device family and failure mode.During this same time frame 437,208 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 0.00004.Per the instructions for use, the user is advised the following: not to apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), and seizure.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 5 X 30MM 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: 17150816
• Report Number: 1017294-2023-00055
• Device Sequence Number: 17129075
• Product Code: GFF
• UDI-Device Identifier: 10845854011744
• UDI-Public: (01)10845854011744(17)271003(30)1(10)1273270
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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 Catalogue Number: E8050LSO
• Device Lot Number: 1273270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic