MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 4-0 S/A TF CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP743D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Before use on patient, it was reported that the needle was found broken at the swage part before use in the packaging.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(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.The following information was requested, but unavailable: procedure name and date? => no further information is available.Event date? => no further information is available.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 275 ug/m.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/09/2022.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: two failed suture needles, labeled as (b)(4), were submitted to fractographic evaluation.The components were identified as product code vcp743d.It was requested that assess the fracture mode of the failures.A fracture was observed at the suture attachment sample a and of sample b.The needles were received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needles.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of (b)(4) revealed the fractures were composed of microvoid coalescence, which is evidence of a ductile overload failure.These were ductile fractures.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.

• Brand Name: VCL+ VIO 8X18IN 4-0 S/A TF CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13001251
• Report Number: 2210968-2021-12571
• Device Sequence Number: 4714811
• Product Code: GAM
• UDI-Device Identifier: 10705031055230
• UDI-Public: 10705031055230
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 04/30/2026
• Device Model Number: VCP743D
• Device Catalogue Number: VCP743D
• Device Lot Number: REMHKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2021
• 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