MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 1 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A301

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Hernia (2240); Not Applicable (3189)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.Additional information was requested and the following was obtained: requested following: lot #? km6525.Please confirm if the event report is in any way related to stratafix product? no.Information.If yes, confirm if any of the following issues noticed: (since event report states ""the surgeon wondered if the fascia had been securely held by the stratafix."") was there any stratafix suture breakage noticed post-op? no.Was there any stratafix suture fixation feature breakage noticed post-op? no.Was there any stratafix suture fixation feature non-engagement in tissue noticed post-op? the stratafix came loose.Was there any stratafix suture knots un-tying noticed post-op? the stratafix came loose.Any issue noticed with the barbs post-op? no.Any other patient consequence / ae outcome? no.And what was done to treat patient? reoperation was done but the detail of reoperation is unknown.Has the patient received or (plan to receive at a later date) any medical / surgical intervention / re operation / additional treatment as a result of the event report? the patient is stable now.The doctor doesn¿t think that the stratafix related to lung hernia because lung hernia might not be occurred if another suture (not ethicon) secured costa correctly.

Event Description

It was reported that a patient underwent an upper lobe lung resection on an unknown date and a barbed suture was used on the fascia.The tissue of the intercostal area which was at a deeper position than the fascia was sutured by another needle-suture other than the barbed suture.Two months following the procedure, a lung hernia occurred.The patient underwent reoperation and the barbed suture was found to be loose.The patient¿s condition became stable postoperatively.The surgeon opined that if the tissue of the intercostal area had been sutured securely, the lung hernia would not have occurred.Thus, it is unlikely that the event was directly caused by the barbed suture.Additional information has been requested and was provided.

Manufacturer Narrative

(b)(4).It was reported that this device is not malfunction reportable.Therefore, this medwatch report is not reportable.

• Brand Name: SFX SYM PDS+ VIO 18IN 1 S/A CTB-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7658764
• MDR Text Key: 113028257
• Report Number: 2210968-2018-74020
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227712
• UDI-Public: 10705031227712
• Combination Product (y/n): N
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: SXPP1A301
• Device Lot Number: KM6525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention