MAUDE Adverse Event Report: CONMED LARGO INFINITY; BIT, SURGICAL

Catalog Number	KRR090
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the device, krr090, infinity retro-reamer, 9mm, was being used during an acl procedure on (b)(6) 2024 when it was reported, ¿during the surgery, while drilling, the tip of the reamer broke and the broken piece was found inside the knee joint, which was identified using c-arm and removed.The patient's condition is good.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed using an alternate same device which caused a 20-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed and evaluated; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, krr090, infinity retro-reamer, 9mm, was being used during an acl procedure on (b)(6) 2024 when it was reported, ¿during the surgery, while drilling, the tip of the reamer broke and the broken piece was found inside the knee joint, which was identified using c-arm and removed.The patient's condition is good.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed using an alternate same device which caused a 20-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The returned used device was evaluated per print and found the reamer broken off at the tip and the reamer cap.The likely cause of this issue is due to the application of excessive force during reaming.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 8 complaints, regarding 9 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 (b)(4).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.

• Brand Name: INFINITY
• Common Device Name: 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: 20084551
• Report Number: 1017294-2024-00100
• Device Sequence Number: 7598963
• Product Code: GFG
• UDI-Device Identifier: 20845854083526
• UDI-Public: (01)20845854083526(17)240729(10)1297408
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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 Expiration Date: 07/29/2024
• Device Catalogue Number: KRR090
• Device Lot Number: 1297408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic