MAUDE Adverse Event Report: CONMED CORPORATION INFINITYTM ANTEROMEDIAL GUIDE R 9/10MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	KBR191
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the kbr191 device was being used during an acl procedure on (b)(6) 2020 when the tip of the device broke at the welding point.The tip was retrieved from the patient and after a 25-minute delay, the procedure was completed successfully with no impact to the patient or the user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of the returned used device, item kbr191, lot# 1047129 found device broken off.The tip was broken off from the bullseye shaft at the welding joint location.The returned device does not show any sign of misuse by the customer, however, scratches (marks) were found at the lower tip shaft.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 two complaints, regarding two 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 0.01.Per the instructions for use, the user is advised the following: warnings: do not use excessive force on instruments to avoid damage or breakage during use.Do not use instruments to pry, as bending or breakage may occur.Do not use improperly or with excessive force, as accuracy may be compromised.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: INFINITYTM ANTEROMEDIAL GUIDE R 9/10MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo, fl
• MDR Report Key: 9751855
• Report Number: 1017294-2020-00082
• Device Sequence Number: 16901460
• Product Code: LXH
• UDI-Device Identifier: 30845854902329
• UDI-Public: (01)30845854902329(11)190926(10)1047129
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: Health Professional
• Device Model Number: KBR191
• Device Catalogue Number: KBR191
• Device Lot Number: 1047129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1