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

Catalog Number KRR090

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

Event Description

The distributor reported on behalf of the customer that the device, krr090, infinity retro-reamer, 9mm, was being used during an arthroscopy procedure on an unknown date when it was reported ¿suddenly the reamer got stuck and we went to see what had happened and it was the front part of the rim that was broken so we had to open another one to be able to continue with the surgery.¿.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 an unknown 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

Update: the classification of the mdr has been updated from injury to malfunction as the evaluation of the device found no fragmentation of the device.Manufacturer narrative: the returned used device, item krr090 was evaluated and could not confirm the reported problem.No fault found.The device did perform as intended during testing.The mechanism does lock when actuated and does release.Tip is actuated at correct position (90 degrees).Passed all function tests.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 12 reports, regarding 13 devices, for this device family and failure mode.During this same time frame 8,158 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 the following: this 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.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

Update: an evaluation of the device found no device problem; therefore, no fragmentation of the device.The incident type has been changed from serious injury to malfunction because of these findings.The distributor reported on behalf of the customer that the device, krr090, infinity retro-reamer, 9mm, was being used during an arthroscopy procedure on an unknown date when it was reported ¿suddenly the reamer got stuck and we went to see what had happened and it was the front part of the rim that was broken so we had to open another one to be able to continue with the surgery.¿.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 an unknown alternate device.There was no report of medical intervention, or extended hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18582098
• MDR Text Key: 333748022
• Report Number: 1017294-2024-00013
• Device Sequence Number: 1
• Product Code: GFG
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KRR090
• Device Lot Number: 1299765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic