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

Model Number J416

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 04/18/2018

Event Type  malfunction  

Event Description

During an inguinal hernia repair the surgeon was suturing using an 3-0 vicryl j416 and the back of the needle with suture thread broke off and fell into pt.The needle broke into 2 pieces.The surgeon was able to locate and remove the fallen item.

• Brand Name: COATED VICRYL
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; route 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 7471917
• MDR Text Key: 106868607
• Report Number: 7471917
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: J416
• Device Lot Number: LK6500
• Other Device ID Number: 3-0 VICRYL SH NEEDLE UNDYED 2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR