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

Catalog Number	KRR100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, krr100, infinity retro-reamer, 10 mm, was being used during an acl repair procedure on (b)(6) 2025 when it was reported, ¿when the surgeon started to drill tibial tunnel retroreamer 10mm broke into the bone.The distal tip of the reamer broke in two parts.Surgeon finally get all the parts.¿.Although the device did fragment, all fragmentation of this device was retrieved from the patient.An alternate same device was used to complete the procedure causing a delay of 20-minutes.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, krr100, infinity retro-reamer, 10 mm, was being used during an acl repair procedure on (b)(6) 2025 when it was reported, ¿when the surgeon started to drill tibial tunnel retroreamer 10mm broke into the bone.The distal tip of the reamer broke in two parts.Surgeon finally get all the parts.¿.Although the device did fragment, all fragmentation of this device was retrieved from the patient.An alternate same device was used to complete the procedure causing a delay of 20-minutes.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The returned used device, item krr100 was evaluated per print krr100 and found device broken off at the tip.Broken piece was returned for evaluation.The root cause cannot be determined, however, based upon evaluation, photos, and the risk document, the likely cause of this event is likely that the tip was not fully locked in the retro-reaming position during the socket drilling.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 not to 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.Exercise care in the use of the retro-reamer.Reamers are designed with a sharp cutting edge that could cut the user.We will continue to monitor per regulatory requirements to help ensure 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: 22182820
• Report Number: 1017294-2025-00066
• Device Sequence Number: 8588852
• Product Code: GFG
• UDI-Device Identifier: 20845854083540
• UDI-Public: (01)20845854083540(17)290729(10)1402886
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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 Catalogue Number: KRR100
• Device Lot Number: 1402886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic