MAUDE Adverse Event Report: CONMED LARGO CONMED; ACCESSORIES,ARTHROSCOPIC

Catalog Number	C8537.1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional 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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, c8537.1, meniscal rasp, 30° bottom and top serrations was being used on (b)(6) 2024and the ¿tip of this device broken during the surgery.The fragment was retrieved using the forceps by the surgeon.¿.There was no impact or injury to the patient.The procedure was completed with an alternate ¿similer other device¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, c8537.1, meniscal rasp, 30° bottom and top serrations was being used on (b)(6) 2024 and the "tip of this device broken during the surgery.The fragment was retrieved using the forceps by the surgeon." there was no impact or injury to the patient.The procedure was completed with an alternate ¿similer other device¿.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history was reviewed, and no data was found.A device history record review found no abnormalities that would contribute to this reported event.(b)(4).Per the instructions for use, the user is advised the following: exercise care in the use of the device to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 20901262
• Report Number: 1017294-2024-00146
• Device Sequence Number: 5004227
• Product Code: NBH
• UDI-Device Identifier: 10845854026755
• UDI-Public: (01)10845854026755(11)170516(10)43343
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: C8537.1
• Device Lot Number: 43343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic