MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A403

Device Problems Use of Device Problem (1670); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem Wound Dehiscence (1154)

Event Date 06/26/2018

Event Type  Injury  

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.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.What was the date of the initial procedure? what tissue layer was the stratafix symmetric suture used on? what was the condition of the tissue the suture was used on? was the fixation tab intact when the suture was placed in the patient? where did the suture start (top to bottom or bottom to top)? what was the suture technique used for stratafix symmetric placement during procedure? what post op date did the patient present with symptoms of dehiscence? was there any patient predisposing event (cough, fall, etc) prior to dehiscence? what is the surgeon opinion as to relationship of the stratafix suture and the patient dehiscence? what was the date of the second procedure? can you describe the appearance of the suture during the second procedure? was the suture found broken, can you identify where (termination, middle, end)? what is patient age, gender, weight, bmi, past medical history? what is the current condition of the patient? was additional product use training provided to pa?.

Event Description

It was reported that a patient underwent a knee procedure on unknown date and barbed suture was used.It was reported that the pa (physicians assistant) had difficulty understanding the use of the barbed suture.On an unknown date, the patient started ambulating and experienced wound dehiscence.A second procedure was indicated to clean and re-close the wound.The current condition of the patient is fine.

• Brand Name: SFX SYM PDS+ VIO 18IN 2-0 S/A CT-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 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7736570
• MDR Text Key: 115648519
• Report Number: 2210968-2018-74782
• Device Sequence Number: 0
• Product Code: NEW
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1A403
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention