MAUDE Adverse Event Report: CONMED 4MM ROUND BUR, EXTRA LONG, CARBIDE

Model Number	5093-228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the reported device has not been returned to conmed for evaluation.However, photographs were sent via email and evaluated per print.The bur broke at the etch safeline and most likely occurred due to excessive force applied by the user on the shaft.A review of the manufacturing documents has verified the devices were produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture that would contribute to this issue.To date, no prior complaints have been reported against this lot of (b)(4) units.(b)(4).A risk analysis was performed and found acceptable.The instructions for use advise the user of 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.This incident type will continue to be monitored within the complaint system to assure patient safety.
Event or Problem Description
A customer reported during use a 00509322800 round bur broke while cutting.Photographic evidence shows the bur broke at the shaft.All detached bur head was removed and a 10-minute surgical delay ensued to obtain and ready an alternative device.No patient injury was reported.To date, additional patient and event information have not been made available.This report is raised on the basis of a reported device malfunction with potential for injury with recurrence.

• Brand Name: 4MM ROUND BUR, EXTRA LONG, CARBIDE
• Common Device Name: ROUND BUR
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7324287
• Report Number: 1017294-2018-00037
• Device Sequence Number: 10790630
• Product Code: GFF
• UDI-Device Identifier: 10845854002490
• UDI-Public: (01)10845854002490(17)220809(30)1()10859089
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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: 08/09/2022
• Device Model Number: 5093-228
• Device Catalogue Number: 00509322800
• Device Lot Number: 859089
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1