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U.S. Department of Health and Human Services

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

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CONMED LARGO CONCEPT GRAFIX CORING REAMER 10MM, QTY 4 Back to Search Results
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.
 
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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 Key16077896
MDR Text Key307978268
Report Number1017294-2022-00117
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10845854021842
UDI-Public(01)10845854021842(17)240624(10)1033663
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/24/2024
Device Model NumberCR8850
Device Catalogue NumberCR8850
Device Lot Number1033663
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 12/14/2022
Initial Date FDA Received12/30/2022
Supplement Dates Manufacturer Received02/06/2023
Supplement Dates FDA Received02/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient EthnicityNon Hispanic
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