MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y527H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional information was requested and the following was obtained: 1.What measures were taken to retrieve the broken piece? - no information.2.Was there any additional tissue damage as a result of searching for the needle piece? - no information.3.Were x-rays taken to locate the needle piece(s)? - no information.4.At what location was the needle found? - no information.5.Was the patient brought back to or to have needle removed or was the needle removed during the initial procedure? - the needle was removed during the initial procedure.6.Does a piece of the needle remain in the patient¿s tissue? - no, it didn't.If yes, what tissue structure is it located? - n/a.7.If retained, what is the surgeon's opinion of consequences to the patient? -n/a.8.What in the physicians opinion are the factors contributing to the event? - no information.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a laparoscopic distal gastrectomy procedure on (b)(6) 2018 and suture was used.During the procedure, the needle was broken at the middle part while anastomosing the bowel.The broken piece of the needle was retrieved.The surgeon commented that his way of suturing was as usual.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
The actual device was returned for analysis.Upon analysis, a fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was intergranular, which is evidence of a brittle failure.This was a non-ductile fracture.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 3-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7416336
• Report Number: 2210968-2018-72063
• Device Sequence Number: 13830642
• Product Code: GAN
• UDI-Device Identifier: 10705031059450
• UDI-Public: 10705031059450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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 Expiration Date: 01/31/2023
• Device Catalogue Number: Y527H
• Device Lot Number: MBZ875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1