MAUDE Adverse Event Report: CONMED LARGO INFINITY RETRO-REAMER, 10MM; BIT, SURGICAL

Model Number KRR100

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

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.Device not yet received.

Event Description

The sales representative reported on behalf of the customer that the krr100, infinity retro-reamer, 10mm, lot number 1232757 x1, was being used during an acl reconstruction procedure on (b)(6) 22 when it was reported, ¿while retro reaming the tibial socket, the tips of 3x krr100's broke¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed with a 10-minute delay.Further assessment questioning found that the device was broken in the patient and the fragmentation of all devices were removed with a grasper.Surgeon suspects it kept breaking on the tibial spine.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The returned device, item krr100, was evaluated by r&d engineer who found the outer cannula broken off at the 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.(b)(4).Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.002.Per the instructions for use, the user is advised the following: inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken, or misaligned parts.Device should only be used by a trained surgeon.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.Exercise care in the use of the handpiece holding the reamer to minimize side or bending loads to the reamer which may cause reamer breakage and/or oversized tunnels.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the krr100, infinity retro-reamer, 10mm, lot number 1232757 x1, was being used during an acl reconstruction procedure on (b)(6) 2022 when it was reported, ¿while retro reaming the tibial socket, the tips of 3x krr100's broke¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed with a 10-minute delay.Further assessment questioning found that the device was broken in the patient and the fragmentation of all devices were removed with a grasper.Surgeon suspects it kept breaking on the tibial spine.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: INFINITY RETRO-REAMER, 10MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16136661
• MDR Text Key: 308679727
• Report Number: 1017294-2023-00003
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 20845854902025
• UDI-Public: (01)20845854902025(17)230906(10)1232757
• 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 Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: KRR100
• Device Catalogue Number: KRR100
• Device Lot Number: 1232757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic