MAUDE Adverse Event Report: CONMED LARGO CONMED; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	16.1018
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that 16.1018, suture retrieval forceps, arthroscopic 3.4 mm x 130 mm device was being used during a shoulder bankart procedure on (b)(6) 2025 when it was reported ¿the tip of our suture retriever broke, the tip of the suture retriever broke while the surgeon was holding and pulling the tissue.¿.Further assessment questioning found that the device did fragment into the surgical site and it was retrieved through use of a suction device.The current status of the patient is "fine".There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that 16.1018, suture retrieval forceps, arthroscopic 3.4 mm x 130 mm device was being used during a shoulder bankart procedure on (b)(6) 2025 when it was reported ¿the tip of our suture retriever broke, the tip of the suture retriever broke while the surgeon was holding and pulling the tissue.¿.Further assessment questioning found that the device did fragment into the surgical site and it was retrieved through use of a suction device.The current status of the patient is "fine".There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event ¿the tip of the suture retriever broke off¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon review of drawing, photos, and the ifu; a possible cause of this event could be excessive force placed on the device.Although this is a reusable device, it is not serviceable.Therefore, a service history is not available for review.A device history record review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised to inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 22130793
• Report Number: 1017294-2025-00055
• Device Sequence Number: 7445095
• Product Code: MDM
• UDI-Device Identifier: 10845854037270
• UDI-Public: (01)10845854037270(11)220531
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 16.1018
• Device Lot Number: LAA13213
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/13/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic