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

Catalog Number SXPP1B420

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

Date sent to the fda: 09/13/2017.(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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: can you describe the surgeon initial technique with stratafix spiral? dr.(b)(6)'s initial technique with stratafix is per the ifu.However, he removes excess suture line by tearing it/breaking it vs cutting it per the ifu.He said he does the same with vloc and has never had a recurrence.How was the stratafix spiral used and secured, what tissue? stratafix was used in a bilateral inguinal hernia repair to fixate the mesh to the defect, and then to close the peritoneum.In suturing mesh, what tissue layers were captured to fixate the mesh? the peritoneum.Was any other fixation method used for the mesh? no.What tissue was the stratafix spiral suture used on? the peritoneum and the hernia defect.What was the condition of the tissue (normal, diseased, weakened)? unknown.However, per my previous case observations, many of dr.(b)(6)'s pts have extremely friable/fragile/weakened peritoneum.Was there any predisposing factor prior to the event (cough, fall, etc)? dr.(b)(6) said the patient abided by all postsurgery instructions of no strenuous activity.What post op day did ¿the suture fail¿? within 24-hours postsurgery as the pt needed to be hospitalized due to severe pain.Re operation occurred on day 4 postop.What is the surgeon opinion as to potential causal factor of the stratafix suture ¿failure¿? dr.(b)(6) said stratafix's barbs/anchors are visually shorter than vloc's barbs/anchors (15 degree angle vs 45 degree angle) therefore, stratafix does not provide enough tissue capture.Can you describe the appearance of the suture during the second procedure? normal.Was the suture intact and pulled through the tissue? yes.What are the patient weight, bmi, medical history? i do not know.Was the suture found broken, if so, where (end, middle, termination)? no, it pulled away in a perfect circle away from the peritoneum.Can you identify the possible lot number used? yes.Code # (b)(4), lot #lcb386.What is the current condition of the patient? doing well recovering.

Event Description

It was reported that a patient underwent a robotic bilateral inguinal hernia procedure on (b)(6) 2017 and barbed suture was used.It was reported that within 24 hours, the patient experienced severe pain.A scan was performed indicating that the suture had pulled off of the peritoneum with the mesh.A second procedure was performed on the day 4 post op.Another device was used to secure the mesh.The patient is reported as doing well recovering.Additional information was requested.

• Brand Name: STRATAFIX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6863299
• MDR Text Key: 86081473
• Report Number: 2210968-2017-70276
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: SXPP1B420
• Device Lot Number: LCB386
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2017
• Date Device Manufactured: 03/01/2017
• 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