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

Model Number	H9110
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination of the returned device found the bur tip was separated from the inner tube at the weld location.The bur tip was also returned.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 were 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 (b)(4) complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: warnings: do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering.Precautions: refer to the appropriate conmed linvatec handpiece instruction manual for the device specific precautions.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This distributor reported that the h9110, 3.5mm sterling spherical bur, qty 6, driver tip broke during a arthroscopic foot surgery on (b)(6) 2018 causing approximately a 15-minute delay.There was no report of injury to the patient or user during the event.The device was reported as having not fallen into the surgical site; therefore, there were no components to retrieve.No further information was made available regarding the patient in this case.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 3.5MM STERLING SPHERICAL BUR, QTY 6
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7658170
• Report Number: 1017294-2018-00097
• Device Sequence Number: 2062880
• Product Code: GFF
• UDI-Device Identifier: 10845854012802
• UDI-Public: (01)10845854012802(17)201111(30)1(10)700784
• 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): 07/03/2018

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: Physician
• Device Expiration Date: 11/01/2020
• Device Model Number: H9110
• Device Catalogue Number: H9110
• Device Lot Number: 700784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1