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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.The following information was requested, but unavailable: what is the lot number? this is a combination product, and the event has been reviewed for both the suture and the triclosan.Ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength = 275 ¿g/m.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a laparoscopic hernia surgery procedure on an unknown date and suture was used.When the suture was inserted into the body through the port, it was confirmed through the camera that the suture had been frayed.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).Date sent to the fda: 4/27/2022.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.H3 investigation summary: visual analysis of the returned product revealed that a paper lid, a winding former with a partially dispensed suture, and a needle-suture piece sample product code vcp305h were received for evaluation.Upon visual inspection of the suture piece the end was noted cut, in the needle-suture piece the swage and attachment area was noted to be as expected, the suture was to be damaged at the surface, in addition, the end was observed to broken possibly from a surgical instrument.The product code vcp305h contains absorbable suture, as the sample was received open, the time of exposed to the environment could not be determined and a functional test cannot be performed.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VICRYL PLUS SUTURE 27"(70CM) 3-0 VIO
• 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: 13850115
• Report Number: 2210968-2022-02012
• Device Sequence Number: 1000306
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: VCP305H
• Device Catalogue Number: VCP305H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown