MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 27"(70CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J353H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was obtained: the product was used for suturing of the uterine muscle layer with cesarean section on (b)(6) 2018.Since the needle fragment was lost, the position of the needle fragment was confirmed by x-ray examination.Reoperation was done on the same day, and the needle fragment was retrieved.As of october 9, 2018, the patient has already been discharged.
Event or Problem Description
It was reported that a patient underwent cesarean section procedure on (b)(6) 2018 and suture was used.The needle broke during use on the uterine muscle layer.The position of the needle fragment was confirmed by x-ray.An additional procedure was performed on the same day to remove the needle fragment.The patient has been discharged from the facility.Additional information will be requested.
Additional Manufacturer Narrative
Pc-(b)(4).Additional information was requested and the following was obtained: if applicable, will product be returned, return date, tracking information - no sample will be returned.What is the patient¿s current status? - the patient has been discharged.The following information was requested but unavailable: the patient demographic info: age, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? what instruments were used to grasp the needle? where was the needle grasped during use? what is physician¿s opinion as to the etiology of or contributing factors to this event.

• Brand Name: VICRYL SUTURE 27"(70CM) 1 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: 8055809
• Report Number: 2210968-2018-77070
• Device Sequence Number: 13933994
• Product Code: GAM
• UDI-Device Identifier: 10705031039209
• UDI-Public: 10705031039209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: J353H
• Device Lot Number: MA6934
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention