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

Model Number	J415H
Health Effect - Clinical Codes	Laceration(s) (1946); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While performing a vaginal repair of a four degree laceration, the tip of the suture needle broke off, remaining in the patients tissue.Needle was located by x-ray and had to be surgically removed.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 7330198
• Report Number: 7330198
• Device Sequence Number: 19218516
• Product Code: GAM
• UDI-Device Identifier: 10705031039643
• UDI-Public: (01)10705031039643
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2018
• Report Date (Section F): 03/06/2018

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: Physician
• Device Model Number: J415H
• Device Catalogue Number: J415H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 03/06/2018