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

Model Number	J327H
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician used 3-0 stratafix suture out of a pacemaker pack to close a pacemaker pocket.Needle driver was used to push the needle through the skin and suture needle broke in half.The needle was stuck in patient's pocket but quickly removed by the physician.Manufacturer response for suture, absorbable, synthetic, polyglycolic acid, coated vicryl (per site reporter).Working with us.

• Brand Name: COATED VICRYL
• 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: 19358043
• Report Number: 19358043
• Device Sequence Number: 3770176
• Product Code: GAM
• UDI-Device Identifier: 10705031038837
• UDI-Public: (01)10705031038837
• 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): 05/01/2024
• Report Date (Section F): 05/01/2024

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: J327H
• Device Catalogue Number: J327H
• 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: 05/21/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2024
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Race: White
• Date Report Sent to FDA: 05/01/2024