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 05/11/2022

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.

Event Description

The sale representative reported that the device, krr100, infinity retro-reamer, 10mm was used during an unknown procedure on approximately (b)(6) 2022 when it was reported that ¿once we began to ream back up on the femoral tunnel we got about halfway up and noticed a strange sound from the reamer.We advanced it back into the joint and saw that it was still flipped.We had some trouble when we tried to flip the reamer back to normal, almost like it was stuck.Once we were able to flip it back, we saw that the blade had been dislodged and was free floating in the joint.We were able to retrieve it with a grasper causing no harm to the patient.¿ the procedure was completed as planned.There was no report of injury, medical intervention, or hospitalization for the patient.A good faith effort was completed for further assessment information; however, no response was received from the reporter to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sale representative reported that the device, krr100, infinity retro-reamer, 10mm was used during an unknown procedure on approximately (b)(6) 2022 when it was reported that ¿once we began to ream back up on the femoral tunnel we got about halfway up and noticed a strange sound from the reamer.We advanced it back into the joint and saw that it was still flipped.We had some trouble when we tried to flip the reamer back to normal, almost like it was stuck.Once we were able to flip it back, we saw that the blade had been dislodged and was free floating in the joint.We were able to retrieve it with a grasper causing no harm to the patient.¿ the procedure was completed as planned.There was no report of injury, medical intervention, or hospitalization for the patient.A good faith effort was completed for further assessment information; however, no response was received from the reporter to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Customer event ¿dislodged¿ was confirmed based on photographic evidence.The device will not be returned for evaluation, but photographic evidence has been provided that confirmed the reported issue.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.A two-year lot history review was conducted and found no other similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 2,862 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 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.Excessive force applied during retrograde drilling can lead to reduced socket sizes.This issue will continue to be monitored through the complaint system to assure patient safety.

• 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: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 14516164
• MDR Text Key: 300468413
• Report Number: 1017294-2022-00063
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 20845854902025
• UDI-Public: (01)20845854902025(17)230903(10)1231618
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: KRR100
• Device Catalogue Number: KRR100
• Device Lot Number: 1231618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic