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

Catalog Number SXPP1A400

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

(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: what tissue type and location of the suture placement? what tissue dehisced? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? what date did the patient present with dehiscence (# post op days)? how was the dehiscence managed? if a surgical intervention was performed, provide surgical/operation notes.The suture was used in one layer closure of tendons and capsule.The tendons dehisced.The tissue was normal.Dehiscence occurred after 7 days from the procedure in one knee and in 14 days in the other knee.Revision surgery took place 6 weeks after the initial procedure.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 condition of the tissue the suture was used on (healthy, diseased, damaged)? 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? when suturing with stratafix symmetric, how far was the bite from the edge of the tissue? were any solutions used during closure (ie antimicrobial)? 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? what degree of tissue healing was noted during the second procedure? was the suture found intact and tissue pulled away from suture? 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?.

Event Description

It was reported that a patient underwent a knee replacement procedure on (b)(6) 2018 and barbed suture was used.The patient experienced dehiscence 14 days post procedure.An additional procedure was indicated for knee revision 6 weeks after the initial procedure.Additional information has been requested.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.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: what was the condition of the tissue the suture was used on (healthy, diseased, damaged)? the tissue was healthy.Was the fixation tab intact when the suture was placed in the patient? yes the fixation tab was intact.Where did the suture start (top to bottom or bottom to top)? top to bottom what was the suture technique used for stratafix symmetric placement during procedure? the first bite was taken in intact tissue before the incision, the normal stitching was done along the incision line with 2 back stitches at the end.When suturing with stratafix symmetric, how far was the bite from the edge of the tissue? few millimetres away from the edge of the incision.Were any solutions used during closure (ie antimicrobial)? yes what post op date did the patient present with symptoms of dehiscence? one week post op for one knee, and 2 weeks post op for the other knee.Was there any patient predisposing event (cough, fall, etc) prior to dehiscence? no what is the surgeon opinion as to relationship of the stratafix suture and the patient dehiscence? the suture did not withstand the high tension applied to it at this very specific area (knees) what was the date of the second procedure? the revision surgery took place on (b)(4).Can you describe the appearance of the suture during the second procedure? it was partially absorbed and easily torn while removing.Was the suture found intact and tissue pulled away from suture? yes was the suture found broken, can you identify where (termination, middle, end)? no what is patient age, gender, weight, bmi, past medical history? (b)(4).What is the current condition of the patient? healthy.

• Brand Name: SFX SYM PDS+ VIO 18IN 1 S/A CTX
• 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.-JUAREZ; 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: 7845568
• MDR Text Key: 119208176
• Report Number: 2210968-2018-75616
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219366
• UDI-Public: 10705031219366
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 08/16/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: SXPP1A400
• Device Lot Number: LMM372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 10/09/2018
• Supplement Dates FDA Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR