MAUDE Adverse Event Report: ETHICON, LLC ETHILON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	1674H
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was using suture 2-0 ethilon when she stated the tip broke off inside the patient.The scrub technician, surgeon, and pa were able to find the tip of the needle.All three verified they found both pieces.The tip and rest of the needle were placed in a separate sponge counter off the field.The sponge counter was placed in a biohazard bag with a patient label and put in the managers office.

• Brand Name: ETHILON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 7973120
• Report Number: 7973120
• Device Sequence Number: 1255021
• Product Code: GAR
• UDI-Device Identifier: 10705031001930
• UDI-Public: (01)10705031001930
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/02/2018
• Report Date (Section F): 10/02/2018

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: Health Professional
• Device Model Number: 1674H
• Device Catalogue Number: 1674H
• Device Lot Number: MDH668
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2018
• Patient Sequence Number: 1
• Patient Weight: 85
• Date Report Sent to FDA: 10/02/2018