MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 3X18IN 2 S/A CTXB CR; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	D10045
Medical Device Problem Code	Material Separation (1562)
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 artificial joint replacement on an unknown date and suture was used.During the procedure, the suture detached from the needle while sewing the fascia.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Additional information was requested and the following was obtained: please provide procedure name and date procedure name is artificial joint replacement surgery.Procedure date is unknown.The following information was requested, but unavailable: please provide lot number no further information is available.Please clarify if the ""other product with another lot"" used after the 3rd time the issue happened is also an ethicon product.If yes please provide product code and lot number no further information is available.How was procedure successfully completed? no further information is available.No further information will be provided.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.¿ trade name - irgacare® ¿ active ingredient(s) ¿ triclosan ¿ dosage form ¿ suture/solid/parenteral ¿ strength ¿ = 275 ¿g/m.Events reported in 2210968-2021-10191, 2210968-2021-10193.

• Brand Name: VCL+ VIO 3X18IN 2 S/A CTXB CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12684784
• Report Number: 2210968-2021-10192
• Device Sequence Number: 11058029
• Product Code: GAM
• UDI-Device Identifier: 10705031134300
• UDI-Public: 10705031134300
• 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
• Report Date (Section B): 10/03/2021

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 Model Number: D10045
• Device Catalogue Number: D10045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1