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 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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 sales representative reported on behalf of the customer that the, krr100, infinity retro-reamer, 10mm was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction procedure and ¿while retro-reaming, the tip of the reamer broke off in 3 pieces.Pieces were retrieved along with the reamer and will be returned to conmed.No patient injury, 10 minute delay¿.After further assessment it was found because the device broke the procedure was completed by switching to a different technique, but were still able to complete the procedure arthroscopically.There was no injury or impact to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event of tip breaking is confirmed.Visual examination of the returned device item krr100, found device broken off at the tip, broken piece was returned for evaluation.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 1 report, regarding 1 device, for this device family and failure mode.During this same time frame 2,720 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 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 was being used on 15apr22 during an anterior cruciate ligament reconstruction procedure and ¿while retro-reaming, the tip of the reamer broke off in 3 pieces.Pieces were retrieved along with the reamer and will be returned to conmed.No patient injury, 10 minute delay¿.After further assessment it was found because the device broke the procedure was completed by switching to a different technique, but were still able to complete the procedure arthroscopically.There was no injury or impact to the patient or user.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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14316906
• MDR Text Key: 299767378
• Report Number: 1017294-2022-00053
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 20845854902025
• UDI-Public: (01)20845854902025(17)230828(10)1230761
• 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: 06/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Model Number: KRR100
• Device Catalogue Number: KRR100
• Device Lot Number: 1230761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic