MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 8X18IN 3-0 S/A SHB CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPB864D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Purulent Discharge (1812); Pocket Erosion (2013); Swelling/ Edema (4577)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on an unknown date and suture was used.The product was used on the subcutaneous during interrupted suturing, the following events occurred.Three weeks after the surgery, in the ward/icu, marks like water swelling occurred.It was similar to when the beard is buried under the skin.It occurred about 3 weeks after the surgery and the knot is pointing downwards so it is unlikely that the knot is exposed on the surface.Additional information was requested.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).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 clarify, what do you mean by "it was similar to when the beard is buried under the skin".Although the suture did not protrude completely to the outside of the epidermis, it was observed to protrude under the skin.When plucked the wound, the suture that had melted a little and was cut was exposed.What tissue was the needle/ suture combination used on? subcutaneous.Was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? unknown.Lot number? unknown.The suture did not protrude out of the epidermis, but it protruded under the skin, and it seemed that there was a slight white pus.There was no redness.When the surgeon lightly scratched the wound, the wound melted somewhat and the broken suture was exposed.The suture was removed in the treatment room, and the wound was closed with tape.There was no surgical site infection, and there were no major problems thereafter.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 this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare, active ingredient(s)- triclosan, dosage form - suture/solid/parenteral, strength -= 275 g /m.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/3/2022.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, the following was obtained: were prescription steroids administered? unknown.Were antibiotics prescribed? if yes, please provide medication name, route and dose.Unknown.Was medical or surgical intervention provided? if yes, please describe.Removal of exposed suture and close the wound with tape in physicians office (not reoperation).Were there signs or symptoms of infection prior to the procedure? unknown.Were cultures performed? if yes, results? unknown.What tissue was the suture used on? subcutis.Was the suture trimmed in physician¿s office? yes.Was the suture removed in a routine post-op procedure? unknown was the suture removed in a reoperation procedure? exposed suture piece was removed without reoperation.Was reoperation necessary to remove the suture and re-close the wound? unknown.But after the removal, there were no problem such as ssi.Size and location of dehiscence? unknown.What post-op date after surgery did the dehiscence occur? dehiscence doesn't occur.What intervention was performed for the dehiscence? dehiscence doesn't occur.Trade name - irgacare; active ingredient(s)- triclosan; dosage form - suture/solid/parenteral; strength -= 275 g /m.

• Brand Name: VCL+ UD 8X18IN 3-0 S/A SHB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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
• MDR Report Key: 14164381
• Report Number: 2210968-2022-02819
• Device Sequence Number: 20089729
• Product Code: GAM
• UDI-Device Identifier: 10705031056664
• UDI-Public: 10705031056664
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VCPB864D
• Device Catalogue Number: VCPB864D
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/03/2022
• 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
• Patient Sex: Unknown