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

Model Number	CR8850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the cr8850, concept grafix coring reamer 10mm, was being used on (b)(6) 2022 during unknown procedure when it was reported ¿reamer metal shredded in the knee causing large hole in tibia.They had to use 15cc bone graft to fill void caused by reamer.¿ there was also 2-hour delay reported in the procedure.Further assessment questioning was requested, to date the reporter has not responded.There was no reported hospitalization for the patient and the current status of the patient is unknown.This report is being raised on the basis of injury due to large hole in the tibia.
Event or Problem Description
The sales representative reported on behalf of the customer that the cr8850, concept grafix coring reamer 10mm, was being used on 18aug22 during unknown procedure when it was reported ¿reamer metal shredded in the knee causing large hole in tibia.They had to use 15cc bone graft to fill void caused by reamer.¿ there was also 2-hour delay reported in the procedure.Further assessment questioning was requested, to date the reporter has not responded.There was no reported hospitalization for the patient and the current status of the patient is unknown.This report is being raised on the basis of injury due to large hole in the tibia.
Additional Manufacturer Narrative
The reported event of ¿reamer shredded in the knee causing a large hole in the tibia¿ is confirmed.The device will not be returned for evaluation however the provided photographic evidence exhibits the reported event.A 2 year lot history review could not be conducted as a valid lot number was not provided.A device history record could not be conducted as a valid lot number was not provided.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 828 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 0.004.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.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Additional information: a 2 year lot history review was conducted and found 2 events for this lot number and failure mode.A device history review found no abnormalities that would contribute to this issue.This information was not available at the time of the final report and has been updated.Manufacturer narrative: the reported event of ¿reamer shredded in the knee causing a large hole in the tibia¿ is confirmed.The device will not be returned for evaluation however the provided photographic evidence exhibits the reported event.A 2 year lot history review could not be conducted as a valid lot number was not provided.A device history record could not be conducted as a valid lot number was not provided.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 828 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 0.004.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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the cr8850, concept grafix coring reamer 10mm, was being used on 18aug22 during unknown procedure when it was reported ¿reamer metal shredded in the knee causing large hole in tibia.They had to use 15cc bone graft to fill void caused by reamer.¿ there was also 2-hour delay reported in the procedure.Further assessment questioning was requested, to date the reporter has not responded.There was no reported hospitalization for the patient and the current status of the patient is unknown.This report is being raised on the basis of injury due to large hole in the tibia.

• Brand Name: CONCEPT GRAFIX CORING REAMER 10MM, QTY 4
• Common Device Name: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 15404245
• Report Number: 1017294-2022-00092
• Device Sequence Number: 6952719
• Product Code: HTO
• UDI-Device Identifier: 10845854021842
• UDI-Public: (01)10845854021842(17)270529(10)1249297
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CR8850
• Device Catalogue Number: CR8850
• Device Lot Number: 1249297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 11/04/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/21/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic