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

Catalog Number S8590

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem Injury (2348)

Event Date 08/15/2019

Event Type  Injury  

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 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
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, FL 33773 ; 7273995358
• MDR Report Key: 8975538
• MDR Text Key: 156947845
• Report Number: 1017294-2019-00115
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 10845854036853
• UDI-Public: (01)10845854036853(17)240610(10)1031269
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S8590
• Device Lot Number: 1031269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other