MAUDE Adverse Event Report: ETHICON INC. STFX SPI PDS+ UNI VIO 36IN 2 S/A CTX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 g/m.(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received as 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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what instruments were used in this procedure to handle the suture? what was the tissue condition (normal, thin, calcified, fragile, diseased)? were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? what was the volume of blood loss? how was the bleeding treated? 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? if applicable, will product be returned? if so, please provide the return date and tracking information.Was the same suture used for both layers? fascia: what suture was used on the fascia? lot number? was there any problem/deficiency with this suture? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? did the fascia layer dehis? what suture was used during the re-operation? please confirm date of re-operation.Please describe the appearance of the suture during the second procedure where the suture was found broken.¿outer layer¿: what suture was used on the ¿outer layer¿? product code/lot number? please specify the exact layer(s) that the suture was used on.Was there any problem with this suture? please describe the appearance of this suture during the re-operation.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? did the outer layer dehis? what suture was used during the re-operation for the ¿outer layer¿? was there any deficiency with the suture placed during the reoperation on (b)(6)?.
Event or Problem Description
It was reported that a patient underwent a total knee replacement procedure on (b)(6)2022 and a barbed suture was used for fascia closure.Post-op, on (b)(6) 2022, an x-ray was done and due to bleeding (that another surgeon thought was under the skin), the surgeon redid the outer layer.The patient got sent home but later in the day, it started to hurt and the bleeding didn´t stop.The patient came back to the clinic and the orthopedic surgeon that did the surgery saw that the barbed had ruptured in 4 places causing a total fascia rupture.The ortho surgeon had to reopen the wound and re-suture.It was opined that the total rupture of fascia closure was due to use of the wrong type of barbed suture.It was stated that the risk of an ssi is high but too early to say.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Device history review : a manufacturing record evaluation was performed for the finished device batch rpbehh and no non-conformances were identified.
Additional 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.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure ¿ a women what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open.What is the physician¿s opinion as to the etiology of or contributing factors to this event? he was handed wrong suture (stratafix spiral instead of symmetric) what suture was used on the fascia? sxpp1b402 lot number? rpbehh did the fascia layer dehis? yes please confirm date of re-operation.(b)(6) did the outer layer dehis? they used skinstaplers and they too had ¿broke open¿ the following information was requested, but unavailable: what instruments were used in this procedure to handle the suture? what was the tissue condition (normal, thin, calcified, fragile, diseased)? were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? what was the volume of blood loss? how was the bleeding treated? other relevant patient history/concomitant medications? what is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.Was the same suture used for both layers? fascia: was there any problem/deficiency with this suture? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what suture was used during the re-operation? please describe the appearance of the suture during the second procedure where the suture was found broken.¿outer layer¿: what suture was used on the ¿outer layer¿? product code/lot number? please specify the exact layer(s) that the suture was used on.Was there any problem with this suture? please describe the appearance of this suture during the re-operation.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what suture was used during the re-operation for the ¿outer layer¿? was there any deficiency with the suture placed during the reoperation on (b)(6)?.

• Brand Name: STFX SPI PDS+ UNI VIO 36IN 2 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15692836
• Report Number: 2210968-2022-08906
• Device Sequence Number: 17819245
• Product Code: NEW
• UDI-Device Identifier: 10705031236059
• UDI-Public: 10705031236059
• Combination Product (Y/N): Y
• Initial Reporter Country: SW
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: SXPP1B402
• Device Catalogue Number: SXPP1B402
• Device Lot Number: RPBEHH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 12/19/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 11/18/2022; 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female