MAUDE Adverse Event Report: CONMED Seahawk; orthopedic manual surgical instrument

Catalog Number	GU2000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the device, gu2000, seahawk suture passer, left, 155 mmx 3.5 mm dia., was used in an unnamed procedure on (b)(6) 2026, and ¿it was reported by the scrub technician that the product ¿ broke within the patient's joint during surgery.However, all fragments were successfully retrieved.No patient injury occurred¿.There was no report of medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
G3 initial awareness date: 01aug 2026.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.

• Brand Name: Seahawk
• Common Device Name: orthopedic manual surgical instrument
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CLASSIC WIRE CUT CO, INC.; 28210 constellation road; valencia CA 91355
• Manufacturer Contact: beth madeline ; 525 french rd; utica, NY 13502 ; +1(727)470-8358
• MDR Report Key: 50301372
• Report Number: 1017294-2026-00154
• Device Sequence Number: 18814471
• Product Code: LXH
• UDI-Device Identifier: 10845854041437
• UDI-Public: (01)10845854041437(11)241213(10)75442
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: GU2000
• Device Lot Number: 75442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown