MAUDE Adverse Event Report: ETHICON, LLC ETHICON; SUTURE, ABSORBABLE, NATURAL

Model Number	G123H
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: a patient in the operating room for a c-section.Suture, after being used, broke off at the needle.This was taken off the field immediately.

• Brand Name: ETHICON
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON, LLC; 475 c street, suite 401; los frailes industrial park; guaynabo PR 00969
• MDR Report Key: 22736601
• Report Number: 22736601
• Device Sequence Number: 9306419
• Product Code: GAL
• UDI-Device Identifier: 10705031037458
• UDI-Public: (01)10705031037458
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2025
• Report Date (Section F): 08/04/2025

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 Model Number: G123H
• Device Catalogue Number: G123H
• Device Lot Number: 101GA3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Date Report Sent to FDA: 08/04/2025