MAUDE Adverse Event Report: CONMED LARGO 1 X 5MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5 EA; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5091-201
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the 00509120100 (qty (b)(4) same lot) was being used during a medium straight side cut on (b)(6) 2021 when it was reported ¿on the same surgery act, they broke 3 times on 4 units bur 5091-201 carbide micro side-cutting straight medium 6 flutes lot:1072359.¿ the procedure was reported as having been completed.There was no report of injury, medical intervention, or hospitalization of the patient.Further assessment information was requested from the reporter and it was found that no fragments were lost in the patient.Any seen fragmentation was removed from the patient using a hemostat device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The devices will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.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.(b)(4).Per the instructions for use, the user is advised to 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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 1 X 5MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5 EA
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• MDR Report Key: 12614462
• Report Number: 1017294-2021-00342
• Device Sequence Number: 11132658
• Product Code: GFF
• UDI-Device Identifier: 10845854001028
• UDI-Public: (01)10845854001028(17)250101(30)1(10)1072359
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: 01/01/2025
• Device Model Number: 5091-201
• Device Catalogue Number: 00509120100
• Device Lot Number: 1072359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1