MAUDE Adverse Event Report: CONMED LARGO 13 X 20MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3; STAPLE, FIXATION, BONE

Catalog Number	7320-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
The customer reported that the 7320-03, 13 x 20mm staplizer bone staple cartridge, qty 3 was being used on (b)(6) 2024 during a right knee revision acl with quads allograft and the ¿conmed stapilizer bone staple cartridge 13mmx 20mm is not firing from the reprocessable 3m/hall staple gun.The cartridge is breaking off pieces of the 13mm staple carrier and debris is going into the patient.This happened with two cartdriges on two different staple guns.Debris was removed from patient's knee¿.There was no report of impact or injury to the patient or user.The procedure was completed with arthrex staples and a 10 minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.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.A two-year review of complaint history revealed there has been a total of 1 reports, regarding 2 devices, for this device family and failure mode.During this same time frame 2,814 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 0.0007.Per the instructions for use, the user is advised the following: the entire surgical team should be familiar with the proper assembly, maintenance and use of the staplizer system.Always match the appropriate staple with the corresponding drive attachment.Protect implantable staples against scratching or nicking; stress concentrations may lead to failure.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 7320-03, 13 x 20mm staplizer bone staple cartridge, qty 3 was being used on (b)(6) 2024 during a right knee revision acl with quads allograft and the ¿conmed stapilizer bone staple cartridge 13mmx 20mm is not firing from the reprocessable 3m/hall staple gun.The cartridge is breaking off pieces of the 13mm staple carrier and debris is going into the patient.This happened with two cartdriges on two different staple guns.Debris was removed from patient's knee¿.There was no report of impact or injury to the patient or user.The procedure was completed with arthrex staples and a 10 minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: 13 X 20MM STAPLIZER BONE STAPLE CARTRIDGE, QTY 3
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 19126877
• Report Number: 1017294-2024-00040
• Device Sequence Number: 12669841
• Product Code: JDR
• UDI-Device Identifier: 10845854015681
• UDI-Public: (01)10845854015681(17)290206(10)1369049
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K840566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7320-03
• Device Lot Number: 1369049
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3M/HALL STAPLE GUN; 3M/HALL STAPLE GUN; ARTHREX STAPLES; ARTHREX STAPLES
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic