MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 8-18"(45CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	ZB740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); No Code Available (3191)
Date of Event	04/16/2018
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.Additional information was requested and the following was obtained: the patient demographic info: weight, bmi at the time of the index procedure => no information.Did the operating surgeon observe any suture deficiency or anomaly before, during after the suture placement? => no, he didn't.Date of reoperation.=> (b)(6) 2018.Other relevant patient history / concomitant medications? => no information.What is the physician¿s opinion as to the etiology of or contributing factors to this event? => 2 surgeons out of 3 whom the sales rep met commented that event occurred because the patient was fat.What is the patient¿s current status? => stable.".
Event or Problem Description
It was reported that a patient underwent open total gastrectomy procedure on (b)(6) 2018 and suture was used to close the wound on fascia with interrupted technique.Post operatively, the patient coughed in the ward.A second procedure was performed on (b)(6) 2018 and suture was found broken, the tissue was not cut when wound dehisced.The surgeon opined that strong force was applied to the suture during bucking since the patient was obese.The patient is reported as stable.Additional information was requested.

• Brand Name: PDS II SUTURE 8-18"(45CM) 0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7495910
• Report Number: 2210968-2018-72662
• Device Sequence Number: 16192182
• Product Code: NEW
• UDI-Device Identifier: 10705031062108
• UDI-Public: 10705031062108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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
• Report Date (Section B): 04/17/2018

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 Catalogue Number: ZB740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention