MAUDE Adverse Event Report: CONMED LARGO INFINITY RETRO-REAMER, 9MM; BIT, SURGICAL

Catalog Number KRR090

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, krr090, infinity retro-reamer, 9mm, was being used during an arthroscopy procedure on an unknown date when it was reported ¿we proceeded to make the tibial tunnel and we indicated to the doctor how he had to drill, when he started everything was going well and suddenly the reamer got stuck and we went to see what had happened and it was that the front part of the brocade was broken so we had to open another one to be able to continue with the surgery.It is noted that it was not a bad brocade by the doctor, but that the wing of the brocade was detached from the body.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed with the use of the same alternate device.There was no report of medical intervention, or extended hospitalization for the patient.This report is being raised on the reported injury due possibility of a foreign body remaining inside of the patient.

Manufacturer Narrative

The device is not being returned and the photographic evidence provided does not appear to verify the complaint; therefore, the reported event cannot be verified.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 13 complaints, regarding 14 devices, for this device family and failure mode.During this same time frame 6,061 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 0.002.Per the instructions for use, the user is advised to 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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, krr090, infinity retro-reamer, 9mm, was being used during an arthroscopy procedure on an unknown date when it was reported ¿we proceeded to make the tibial tunnel and we indicated to the doctor how he had to drill, when he started everything was going well and suddenly the reamer got stuck and we went to see what had happened and it was that the front part of the brocade was broken so we had to open another one to be able to continue with the surgery.It is noted that it was not a bad brocade by the doctor, but that the wing of the brocade was detached from the body.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.The procedure was completed with the use of the same alternate device.There was no report of medical intervention, or extended hospitalization for the patient.This report is being raised on the reported injury due possibility of a foreign body remaining inside of the patient.

• Brand Name: INFINITY RETRO-REAMER, 9MM
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17281245
• MDR Text Key: 318647952
• Report Number: 1017294-2023-00062
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 20845854902001
• UDI-Public: (01)20845854902001(17)230925(10)1236441
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2023
• Device Catalogue Number: KRR090
• Device Lot Number: 1236441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic