MAUDE Adverse Event Report: CONMED CORPORATION 9 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4; BIT, SURGICAL

Catalog Number	S8590
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer returned for the evaluation a total of three (3) units; one (1) used and two (2) not used (new).Examination found only one (1) used item to have the laser etch line incorrect, the laser etch line was etched in on the opposite side of the cutting edge tip.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.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, 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).Conmed encourages the inspection and/or testing of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that s8590 device was being used during a knee surgery case on (b)(6) 2019.The reporter states that "patient injury occurred because the indicator line was printed on the opposite side and the condyle was hit with the drill bit." there was no reported delay in the procedure and the procedure was completed successfully per the reporter.Further assessment information was requested from the facility; however, the reporter has not responded to any request that have been made.This report is being raised on the basis of injury due to facility reporting injury to patient.

• Brand Name: 9 X 229MM (9IN) SENTINEL CANNULATED DRILL BIT, QTY 4
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 8975538
• Report Number: 1017294-2019-00115
• Device Sequence Number: 11482263
• Product Code: GFG
• UDI-Device Identifier: 10845854036853
• UDI-Public: (01)10845854036853(17)240610(10)1031269
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2024
• Device Catalogue Number: S8590
• Device Lot Number: 1031269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other