MAUDE Adverse Event Report: CONMED 1 X 5MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5EA

Model Number	5091-201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was discarded by the user facility due to biomaterial on the device; therefore, an evaluation is unable to be performed.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.No prior complaints have been received for this specific lot of (b)(4) units.A two-year historical complaint review revealed 6 similar events involving (b)(4) devices have been reported for this product.In that same timeframe, (b)(4) devices have been manufactured and shipped worldwide.A risk analysis was performed and this failure is deemed acceptable.The customer is advised of the following warnings and precautions set forth in the instructions for use.After use blades, burs and tubing sets may be a potential biohazard and should be handled and disposed in accordance with acceptable medical practice and applicable local and national requirements.Do not use burs for plunge cutting.Injury or damage may occur.Disposable blades and burs are supplied sterile and are for single use only.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.Direct contact of the rotating cutting edge of shaver blades and burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices.If contact does occur, shaver blades can break, seize, or shed metal particles.Shaver blade or bur should be examined for damage and replaced if necessary.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 through the complaint system to assure patient safety.
Event or Problem Description
A conmed affiliate reported on behalf of a user facility that during a mandible procedure, the tip of a 00509120100 side-cutting bur broke.The broken tip was captured by the suction line.This did not cause a significant delay and the procedure was completed as scheduled with no patient injury.The reported device was discarded by the facility due to biomaterial still present on the device.Additional patient information and event details have not been provided.This report is raised on the basis of a device malfunction with potential for patient injury with recurrence.

• Brand Name: 1 X 5MM SIDECUTTING BUR, MEDIUM, STRAIGHT, 5EA
• Common Device Name: SIDECUTTING BUR
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7047652
• Report Number: 1017294-2017-00121
• Device Sequence Number: 944303
• Product Code: GFF
• UDI-Device Identifier: 10845854001028
• UDI-Public: (01)10845854001028(17)220501(30)1(10)833993
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

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: Other
• Device Expiration Date: 05/01/2022
• Device Model Number: 5091-201
• Device Catalogue Number: 00509120100
• Device Lot Number: 833993
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1