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

Model Number	J416H
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The physician requested a 3-0 vicryl suture on an sh needle (j416h) for a 3c episiotomy repair.The suture was given to the md and a stitch was attempted.The metal needle broke in two in the patient's tissue.The physician had a difficult time trying to find the broken piece.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 16459114
• Report Number: 16459114
• Device Sequence Number: 2393702
• Product Code: GAM
• UDI-Device Identifier: 10705031039667
• UDI-Public: (01)10705031039667
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/23/2023
• Report Date (Section F): 02/23/2023

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: J416H
• Device Catalogue Number: J416H
• Device Lot Number: SDMMQQ
• 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: 03/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 02/23/2023