MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 18IN 3-0 SA PS PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Skin Inflammation/ Irritation (4545)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right total knee arthroscopy on (b)(6) 2021 and a barbed suture was used.On (b)(6) 2021, the patient called the office of the provider with concerns about their incision.On (b)(6) 2021, the patient was seen in the clinic and had wound dehiscence at the proximal and distal ends of the incision.The patient possibly experienced local redness and pus.The patient was instructed to apply betadine twice a day.On (b)(6) 2022, the patient was seen in the office and it was determined that irrigation and debridement was not necessary.The suture tails were removed in the areas of dehiscence.The incision is currently healing without issue.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 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: lot number for stratafix spiral monocryl plus - sxmp1b111? unknown.Lot number for stratafix spiral pds plus - sxpp1b411? unknown.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? yes.What tissue dehisced? subcutaneous and subcuticular.How was the skin closed? it was closed with sxpp1b411.Proper initiation and termination of the suture was done.Note: events reported in 2210968-2022-00743.

• Brand Name: SFX SPI MCRYL+ UNI 18IN 3-0 SA PS PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13423845
• Report Number: 2210968-2022-00742
• Device Sequence Number: 14388805
• Product Code: GAM
• UDI-Device Identifier: 10705031236660
• UDI-Public: 10705031236660
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: SXMP1B111
• Device Catalogue Number: SXMP1B111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female