MAUDE Adverse Event Report: CONMED LARGO MINI-AGGRESSOR; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number	32.16334
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 32.16334, mini-aggressor forceps, 15° up, 2.75 mm x 130 mm, was being used during an arthroscopy procedure on (b)(6) 2024 when it was reported, ¿rod fracture during operation.".There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment was requested and found that the device was broken during use.A fragment fell into the patient and was retrieved with forceps.The procedure was completed with a device from another set.The incident caused a 10-minute delay in the procedure.The patient status is listed as ¿steady¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.
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.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.The service history was reviewed, and no data was found.A two-year review of complaint history revealed there has been a total of 30 complaints, regarding 30 devices, for this device family and failure mode.During this same time frame 10,160 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 0.003.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 32.16334, mini-aggressor forceps, 15° up, 2.75 mm x 130 mm, was being used during an arthroscopy.Procedure on (b)(6)2024 when it was reported, ¿rod fracture during operation.".There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment was requested and found that the device was broken during use.A fragment fell into the patient and was retrieved with forceps.The procedure was completed with a device from another set.The incident caused a 10-minute delay in the procedure.The patient status is listed as ¿steady¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: MINI-AGGRESSOR
• Common Device Name: FORCEPS, GENERAL & PLASTIC SURGERY
• 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: 20693775
• Report Number: 1017294-2024-00132
• Device Sequence Number: 15599416
• Product Code: GEN
• UDI-Device Identifier: 10845854038093
• UDI-Public: (01)10845854038093(11)240222
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 32.16334
• Device Lot Number: LAA03273
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic