MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Seroma (2069); Hernia (2240)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 ug/m.Component code: g07002 device not returned.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: it is currently unknown whether the correct product code is sxpp1a443 or sxpp1a444.The sales rep is waiting for the medical record to know for sure.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? did the stratafix suture break? if so, where was the break noted (termination, middle, end)? what symptoms did the patient experience following the index surgical procedure? onset date? what tissue dehisced? were there any precipitating stress factors that led to the suture breaking? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe the appearance of the suture during the second procedure.Other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product code sxpp1a443 or sxpp1a444? lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.Surgeon¿s name?.

Event Description

It was reported that a patient underwent a fascia closure procedure on an unknown date and barbed suture was used.At the post-surgery check-up, about 3 months, the patient developed a laparocele.The suture opened in the center and not at the ends.The patient required a revision surgery.Additional information was requested.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: 3/29/2023 this is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: a3, a4, b7, e1, h6 health effect - clinical code additional information was requested, and the following was obtained: 1.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: -> male, 80 kg, year of birth 1959, bmi 27.76 2.Date and name of index surgical procedure? -> median laparotomy with viscerolysis and cholecystectomy, estimated date january 2023 3.The diagnosis and indication for the index surgical procedure? -> complicated acute cholecystitis likely cystic artery pseudoaneurysm 4.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? -> laparoscopic 5.What was the tissue condition (normal, thin, calcified, fragile, diseased)? -> normal 6.Was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? -> yes 7.Were two reverse stitches performed across the incision prior to closure? -> yes 8.Did the stratafix suture break? -> no 9.If so, where was the break noted (termination, middle, end)? -> the break was noted at 1/3 of the suture 10.What symptoms did the patient experience following the index surgical procedure? -> subcutaneous seroma with evisceration 11.Onset date? unk 12.What tissue dehisced? yes 13.Were there any precipitating stress factors that led to the suture breaking? n/a 14.Onset date/time of dehiscence? (# post op days) -> at check-up exam after 10 days from procedure 15.How was the dehiscence managed? second surgery 16.Please describe any surgical intervention required for the wound dehiscence including date and findings.-> re-laparotomy 17.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no, the re-intervention was closed with another suture thread (vicryl detached sutures) 18.Please describe the appearance of the suture during the second procedure.The margins of the fascia were normal, nothing to report about this 19.Other relevant patient history/concomitant medications? no 20.What is the physician¿s opinion as to the etiology of or contributing factors to this event? none 21.What is the patient's current status? fine following re-intervention 22.Product code sxpp1a443 or sxpp1a444? lot number? unknown at the moment 23.If applicable, will product be returned? no, it is implanted 24.If so, please provide the return date and tracking information.N/a.

• Brand Name: STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16433382
• MDR Text Key: 310130856
• Report Number: 2210968-2023-01339
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2023
• 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
• Patient Sex: Male
• Patient Weight: 80 KG