MAUDE Adverse Event Report: CONMED LARGO 5 X 38MM E9000 FLUTED LOW SPEED OPTIMUM BUR, ROUND, CARBIDE; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	E8150LSO
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
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.Device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer on (b)(6) 2022 the device, e8150lso, 5 x 38mm e9000 fluted low speed optimum b was being used when it was reported that ¿the bur is broken during the surgery¿.After further assessment it was found that "yes, the bur broke during the surgery: the surgeon was performing a mastoidectomy and, when he started using the 5mm bur, it met a kind of bone ¿step¿, whose impingement caused the bur rupture." the spherical tip of the burr was fragmented and retrieved using a forcep.It was also found that ¿the patient wasn¿t affected by the incident¿ and no report of medical intervention or hospitalization for the patient.The procedure was completed with a one or two minute delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer on 19may2022 the device, e8150lso, 5 x 38mm e9000 fluted low speed optimum b was being used when it was reported that ¿the bur is broken during the surgery¿.After further assessment it was found that "yes, the bur broke during the surgery: the surgeon was performing a mastoidectomy and, when he started using the 5mm bur, it met a kind of bone ¿step¿, whose impingement caused the bur rupture." the spherical tip of the burr was fragmented and retrieved using a forcep.The procedure was completed with a one or two minute delay.It was also found that ¿the patient wasn¿t affected by the incident¿ and no report of medical intervention or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
To date, the reported device has not been returned to conmed for evaluation and no photographic evidence was provided.Should the device be returned, an evaluation will be performed.Upon completion of the complaint investigation a supplemental and final report will be filed.Otherwise this filing will stand as the final report.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 12 complaints, regarding 14 devices, for this device family and failure mode.During this same time frame 446,575 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 ifu w41-181-004, overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 14567576
• Report Number: 1017294-2022-00064
• Device Sequence Number: 5095592
• Product Code: GFF
• UDI-Device Identifier: 10845854011713
• UDI-Public: (01)10845854011713(17)260913(30)1(10)1194111
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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 Expiration Date: 09/13/2026
• Device Model Number: E8150LSO
• Device Catalogue Number: E8150LSO
• Device Lot Number: 1194111
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic