MAUDE Adverse Event Report: CONMED OVAL BUR, MEDIU,. 4X8MM

Model Number	5091-236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device was returned to conmed for evaluation.Visual inspection of the device verified the reported issue "bur head broke".The bur was found to be broken off at the etch safe line.The bur shaft was not returned for evaluation and no discrepancies were found with the manufactured bur head.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.A two-year historical complaint review revealed 30 similar complaints involving 36 devices for this product family.(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 a shoulder surgery, the head of a 00509123600 oval bur broke.Follow-up confirmed the breakage occurred while the bur was tested by the nurse before start of surgery.The bur did not break in the patient and all broken pieces were accounted for.An alternative bur was used in a micropower plus drill on the patient and the procedure was completed with a ten minute surgical delay.No patient injury was reported.This reported is raised on the basis of a device malfunction with potential for injury with recurrence.

• Brand Name: OVAL BUR, MEDIU,. 4X8MM
• Common Device Name: BUR
• Manufacturer (Section D): CONMED; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7207353
• Report Number: 1017294-2018-00011
• Device Sequence Number: 1485563
• Product Code: GFF
• UDI-Device Identifier: 10845854007488
• UDI-Public: (01)10845854007488(17)190516(30)1(10)562482
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/19/2018

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: Nurse
• Device Expiration Date: 05/01/2019
• Device Model Number: 5091-236
• Device Catalogue Number: 00509123600
• Device Lot Number: 562482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1