MAUDE Adverse Event Report: CONMED LARGO 3.5MM STERLING SPHERICAL BUR, QTY 6; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	H9110
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
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 : device not yet received.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, h9110, 3.5mm sterling spherical bur, qty 6 was being used on (b)(6) 2023 during an arthroscopic procedure and ¿it was reported that when an abrader bar was used to resect the osteophyte at the ankle as, the abrader bar was broken during the surgery.The broken tip was recovered, the new bar was opened, and the operation was completed without any problems¿.There was no impact/injury for the patient or user.Further assessment found that there was no report of medical intervention or prolonged hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, h9110, 3.5mm sterling spherical bur, qty 6 was being used on (b)(6) 23 during an arthroscopic procedure and ¿it was reported that that when an abrader bar was used to resect the osteophyte at the ankle as, the abrader bar was broken during the surgery.The broken tip was recovered, the new bar was opened, and the operation was completed without any problems¿.There was no impact/injury for the patient or user.Further assessment found that there was no report of medical intervention or prolonged hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The returned used device, item h9111 was inspected per print a30-383-001 and found inner bladed broken off at the tip.Root cause cannot be determined, however, based upon the evaluation of the device and ifu; a possible cause of this event could be excessive force.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 4 reports, regarding 9 devices, for this device family and failure mode.During this same time frame 302,653 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 the following: do not 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), motor seizure, and overheating.Additionally, the same ifu states: always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 3.5MM STERLING SPHERICAL BUR, QTY 6
• 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 17215609
• Report Number: 1017294-2023-00058
• Device Sequence Number: 3023114
• Product Code: GFF
• UDI-Device Identifier: 10845854012802
• UDI-Public: (01)10845854012802(17)271108(10)1271825
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/11/2023

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: H9110
• Device Lot Number: 1271825
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic