MAUDE Adverse Event Report: ETHICON INC. STRATAFIX; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A400

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Wound Dehiscence (1154); Not Applicable (3189)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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? can you describe the surgeon initial technique with stratafix symmetric tab? what was the indication for using 3 stratafix symmetric suture during this one patient procedure? was there any anomaly or issue with the device/ fixation tab prior to use? what tissue was the stratafix symmetric suture used on? what was the condition of the tissue (normal, diseased, weakened)? was the fixation tab intact when the suture was placed in the patient? was there any predisposing factor prior to the event (cough, fall, etc)? what is the surgeon opinion as to relationship of the stratafix suture and the dehiscence? can you describe the appearance of the suture during the second procedure? was the device fixation tab intact during the second procedure? what are the patient weight, bmi, medical history? what is the current condition of the patient?.

Event Description

It was reported that a patient underwent an abdominal closure procedure on (b)(6) 2017 and suture was used.At post-op day five, the surgeon reported that the patient was brought back to the or for a wound dehiscence.The suture appeared to have slipped when the incision was inspected.The surgeon closed the wound with another suture.Additional information has been requested.

Manufacturer Narrative

Additional information: patient codes: (b)(4) ¿ surgical intervention.

• Brand Name: STRATAFIX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC. JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarrez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6855983
• MDR Text Key: 85735592
• Report Number: 2210968-2017-70245
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1A400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• 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