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

Model Number KRR090

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2023

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 : device not yet received.

Event Description

The distributor reported on behalf of their customer that the krr090, infinity retro-reamer, 9mm, was being used during an acl reconstruction procedure on (b)(6) 2023 when it was reported, ¿the cutting tip is broken.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.Further assessment questions found that the device broke, and a fragment fell into patient.Fragment was removed using a grasper or kelly straight clamp.The procedure was completed with a 10-delay using an alternate device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The returned used device, item krr090 was evaluated.The tip found still attached.The device did not perform as intended during testing.The mechanism does not lock when actuated and does not release.The tip is not actuated at the correct position (90 degrees).The device is locked in.Failed all function tests.Note: no fragmentation was found in the evaluation.The probable cause for this is the application of too much force.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 complaints, regarding 13 devices, for this device family and failure mode.During this same time frame 5,798 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: 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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the krr090, infinity retro-reamer, 9mm, was being used during an acl reconstruction procedure on 31jan23 when it was reported, ¿the cutting tip is broken.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.Further assessment questions found that the device broke, and a fragment fell into patient.Fragment was removed using a grasper or kelly straight clamp.The procedure was completed with a 10-delay using an alternate device.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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17105214
• MDR Text Key: 316934782
• Report Number: 1017294-2023-00052
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 20845854083526
• UDI-Public: (01)20845854083526(17)240107(10)1255686
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: KRR090
• Device Catalogue Number: KRR090
• Device Lot Number: 1255686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic