MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP305H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 ¿it was found that the suture had been frayed, so use was stopped.¿ did the suture fray during use on the patient or upon handling? please clarify.The following information was requested, but unavailable: do you have a photo for visual analysis? no photos are available.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.
Event or Problem Description
It was reported that a patient underwent a spinal procedure on (b)(6) 2021 and suture was used.During the procedure, it was reported by a sales rep that, during a spinal surgery, when taking out from the package, it was found that the suture had been frayed, so use was stopped.Then the surgery was completed with another needle-suture.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11583570
• Report Number: 2210968-2021-02855
• Device Sequence Number: 11502075
• Product Code: GAM
• UDI-Device Identifier: 10705031052130
• UDI-Public: 10705031052130
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 06/30/2025
• Device Model Number: VCP305H
• Device Catalogue Number: VCP305H
• Device Lot Number: QHMBRX
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1