MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 4-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J743D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.  attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure? data and name of index surgical 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? please clarify the issue with the device during use, i.E., did the needle break, did the needle pull off from the suture? were x-rays performed to localize the needle fragment? please clarify - did one needle stay in the patient¿s head? were the needle piece(s) retrieved during the same procedure? does the piece/device remain retained in the patient¿s tissue? if the piece(s) were retained, where are they located / in what structure? if retained, were there any patient consequences? is the device available to be returned for evaluation? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle stayed in patient¿s head.Additional information has been requested.

• Brand Name: VICRYL SUTURE 18"(45CM) 4-0 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: 7876812
• Report Number: 2210968-2018-75830
• Device Sequence Number: 16186430
• Product Code: GAM
• UDI-Device Identifier: 10705031042674
• UDI-Public: 10705031042674
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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: 04/30/2023
• Device Catalogue Number: J743D
• Device Lot Number: MEM757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention