MAUDE Adverse Event Report: ETHICON, LLC MONOCRYL; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	MCP496G
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Several suture from the same lot broke while using.

• Brand Name: MONOCRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; 475 c street, suite 401; los frailes industrial park; guaynabo PR 00969
• MDR Report Key: 21651721
• Report Number: 21651721
• Device Sequence Number: 9401940
• Product Code: GAM
• UDI-Device Identifier: 30705031046591
• UDI-Public: (01)30705031046591(17)260630(10)10276(20)13
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/13/2025
• Report Date (Section F): 03/13/2025

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: Other
• Device Model Number: MCP496G
• Device Catalogue Number: MCP496G
• Device Lot Number: 10276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 03/13/2025