MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 27IN 3-0 S/A X-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXPP1B120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fall (1848)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.H6 component code: g07002 device not returned.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: name of surgery? total knee arthroplasty.Patient demographics: initials / id, gender, age or date of birth; bmi? unk.Product lot of product used? unk.Current patient status: no problem.Epidermis: clr222us was used intraoperatively, but product characteristics were not announced to the nurse.It was removed 2 days after surgery and a wayward taping was applied.Dermis: sxpp1b120 was used intraoperatively.However, suture breakage occurred due to the patient fall.Fascia: sxpp1a440 was used.However, suture breakage occurred during the fall.The wound was closed early and the patient was discharged from the hospital.There is no doubt that the patient's violent fall caused the suture breakage.Related medwatch reports: 2210968-2023-09019.
Event or Problem Description
It was reported that a patient underwent a total knee arthroplasty procedure on (b)(6) 2023 and barbed suture was used.On (b)(6) 2023, the patient fell during rehabilitation and the wound opened by accident and was re-sutured.The surgeon said this was not a product defect.The patient is in the hospital.Additional information was requested.

• Brand Name: SFX SPI PDS+ UNI VIO 27IN 3-0 S/A X-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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 PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18163616
• Report Number: 2210968-2023-09018
• Device Sequence Number: 15114820
• Product Code: NEW
• UDI-Device Identifier: 10705031240865
• UDI-Public: 10705031240865
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K182873
• 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
• Report Date (Section B): 11/17/2023

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 Catalogue Number: SXPP1B120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown