MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X27IN 0 S/A MO-4 CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCPP71D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (b)(4) device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: was the needle found broken/ bent / are the metal fragments of the needle that were found in the package? what was the name of the initial procedure? no procedure info available.What was the procedure date? unknown.Do you have any photos of the metal fragments noted on one of the needles? no.Were the suture seals on the foil still intact when the package was opened? unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Trade name: (b)(4) active ingredient(s): triclosan.Dosage form: suture/solid/parenteral.Strength: 275 g/m.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was to be used.During the procedure, when the suture was opened there were metal fragments noted on one of the needles.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 06/15/2021.H6 component code: g07002 - no device problem found.Additional information: 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 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 evaluation: h3 investigation summary: a package of suture needles, labeled as (b)(4), was submitted for fractographic evaluation.The component was identified as product code vcpp71d.It was requested to assess the fracture mode of the failure.The needles were new and not fractured; therefore, no further analysis was performed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The evaluation of (b)(4) revealed the needles were unfractured.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 ¿g/m.

• Brand Name: VCL+ VIO 8X27IN 0 S/A MO-4 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11857938
• Report Number: 2210968-2021-04774
• Device Sequence Number: 3962075
• Product Code: GAM
• UDI-Device Identifier: 10705031056862
• UDI-Public: 10705031056862
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 02/28/2025
• Device Model Number: VCPP71D
• Device Catalogue Number: VCPP71D
• Device Lot Number: QCMBDH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1