MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP269H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).
Event or Problem Description
It was reported that a patient underwent a posterior lumbar interbody fusion l-4-5 procedure on (b)(6) 2023 and suture was used.Post op the sutures were not dissolving and were being rejected.Additional information was requested.
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: a2, a3, a4, b7.Additional information was requested, and the following was obtained: age, gender, weight, bmi at the time of index procedure 44f, 141.568kg, 52.What was the tissue condition (normal, thin, calcified, fragile, diseased) normal for vicryl suture- how was the suture placed (interrupted or continuous)? running stich (continuous?) for vicryl suture - how was the suture originally tied (multiple knots, square knot, etc.)? unknown.For stratafix symmetric pds plus - was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? n/a.For stratafix symmetric pds plus - were two reverse stitches performed across the incision prior to closure? n/a.What tissue layer(s) dehisced? subcutaneous.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no documentation or report of issues.Other relevant patient history/concomitant medications? n/a.What is the physician¿s opinion as to the etiology of or contributing factors to this event? wound care provider, ""believe this in my professional opinion is once again the sutures that are meant to be dissolved but the body but inside the body rejects them and pushes them out causing dehiscence" corrected information: h6 type of investigation.

• Brand Name: VCL+ UD 27IN 2-0 S/A CT-2
• 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 ; 9083863534
• MDR Report Key: 17440504
• Report Number: 2210968-2023-05529
• Device Sequence Number: 14179437
• Product Code: GAM
• UDI-Device Identifier: 10705031051911
• UDI-Public: 10705031051911
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VCP269H
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 08/24/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/02/2023; 08/30/2023
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 141 KG