MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 5-0 S/A PS-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP500G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Local Reaction (2035); Scar Tissue (2060)
Date of Event	12/18/2023
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 ¿ = 472 g/m.H6 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: what is the procedure name? bunionectomy: cpt ¿ capsule mttarphlngl jt w/wo tenorrhaphy.What is the procedure date? (b)(6) 2023.What date did the reaction occur on? suspected (b)(6) 2023, then again on (b)(6) 2023, confirmed on (b)(6) 2024.What does the reaction look like and how large of an area does the reaction cover? looks like incision is pulling apart.Do you have any pictures of the reaction? yes ¿ see attached.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Anti-biotics were prescribed at time of surgery and entire bottle consumed as instructed.Re-operation was conducted on (b)(6) 2024 ¿ this surgery cleaned out the scar tissue that had developed inside the toe, the outside scar, and a steel pin was placed inside the toe to hold it straight.What is the most current patient status? continuing physical therapy until (b)(6) 2024 then will re-evaluate.Can you identify the product code and lot number of the product that was used? yes ¿ it is vicryl 5/0, lot sdmpzu.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Please clarify if all 3 sutures used were all related to this event.Vcp500g/ lot sdmpzu quantity 1.Vcp232h/ sl2beo (invalid lot #) quantity 1.Vcp823g (lot unknown) quantity 1.Or was only vicryl 5/0, vcp500g/ lot sdmpzu related to this event? if yes, what is the quantity that contributed to this event? sl2beo is an invalid lot number.Please provide a valid lot # for vcp232h.Did the patient experience a wound dehiscence? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? what tissue dehisced? please describe the appearance of the suture during the second procedure.Did the suture untie, break, or pull out of the tissue? were there any patient stress factors that led to the suture untying, breaking or pulling out of the tissue? onset date/time of dehiscence? (# post op days) how was the dehiscence managed? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? 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.Surgeon¿s name? investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show three open aluminum packs, and the patient's scarring is also shown in two other images.The image is not clear to determine the failure mode.Based on the photo review, no conclusion or root cause could be determined.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported that a patient underwent a bunionectomy: cpt ¿ capsule mttarphlngl jt w/wo tenorrhaphy procedure on (b)(6) 2023 and suture was used.The patient experienced a post op reaction.Additional information was requested.

• Brand Name: VCL+ UD 18IN 5-0 S/A PS-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19398716
• Report Number: 2210968-2024-05586
• Device Sequence Number: 6955308
• Product Code: GAM
• UDI-Device Identifier: 10705031053854
• UDI-Public: 10705031053854
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2024

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 Catalogue Number: VCP500G
• Device Lot Number: SDMPZU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2022
• 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