MAUDE Adverse Event Report: CONMED LARGO CONCEPT GRAFIX CORING REAMER 10MM, QTY 4

Model Number CR8850

Device Problem Material Fragmentation (1261)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of the customer that the device, cr8850 concept grafix coring reamer 10mm, qty 4 was being used on (b)(6) 2202 during an anterior cruciate ligament reconstruction and ¿reamer broken during use¿.There was no impact or injury to the patient.The procedure was completed with an alternate same device.After further assessment it was found that fragments fell into the surgical site and were retrieved.There was a 15-30 minute delay, ¿because the surgeon removed the broken piece of this complaint product¿.There was no report of medical/surgical intervention or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The returned used device, item cr8850 was evaluated and confirm the reported problem and found reamer broken off.The failure was due to user error and happens when the guide pin comes in contact with the cutting edge.This failure mode is addressed in the ifu.Examination performed per print cr8850.Reamer broken off at the etching lines.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.(b)(4).Per the instructions for use, the user is advised the following: avoid misalignment of the coring reamer to the guide pin.Failure to do so can cause the coring reamer to come in contact with the guide pin while drilling which may damage the coring reamer or guide pin and may cause widening of the bone tunnel.Additionally, the ifu goes on to state that care should be exercised in the use of the powered instrument to minimize side or bending loads to the coring reamers which may cause them to break.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of the customer that the device, cr8850 concept grafix coring reamer 10mm, qty 4 was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction and ¿reamer broken during use¿.There was no impact or injury to the patient.The procedure was completed with an alternate same device.After further assessment it was found that fragments fell into the surgical site and were retrieved.There was a 15-30 minute delay, ¿because the surgeon removed the broken piece of this complaint product¿.There was no report of medical/surgical intervention or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: CONCEPT GRAFIX CORING REAMER 10MM, QTY 4
• Type of Device: REAMER
• 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: 16077896
• MDR Text Key: 307978268
• Report Number: 1017294-2022-00117
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10845854021842
• UDI-Public: (01)10845854021842(17)240624(10)1033663
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CR8850
• Device Catalogue Number: CR8850
• Device Lot Number: 1033663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic