MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP340H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2021 and suture was used.It was reported that the suture broke and the wound was opened.It is unknown when the event occurred.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.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.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.It was reported that "the suture broke and wound opened.They happened with another patient last week.They pulled all the vycryl o with the ct1 needle with the lot numbers".Two files were opened to capture each patient: patient 1: (b)(4), patient 2: (b)(4).For each of the two patients, please provide the following: please provide the product code and lot number.When did the event occur? intra-op or post-op? procedure date? if post-op, what post-op date after surgery did the dehiscence occur? was there any medical or surgical intervention performed to treat the opened wound (re-operation; re-suturing; prescription steroids; antibiotics prescribed)? if so, please clarify.What is the most current patient status? trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.Note: events reported: 2210968-2021-12701 and 2210968-2021-12699.

• Brand Name: VCL+ VIO 27IN 0 S/A CT-1
• 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: 13025482
• Report Number: 2210968-2021-12700
• Device Sequence Number: 14712454
• Product Code: GAM
• UDI-Device Identifier: 10705031052499
• UDI-Public: 10705031052499
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 02/07/2022

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 Expiration Date: 12/31/2024
• Device Model Number: VCP340H
• Device Catalogue Number: VCP340H
• 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: 11/18/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 02/07/2022
• 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