MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP317H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the analysis of the returned product that suture degradation was observed.It was reported that a patient underwent a plastic surgery on an unknown date and suture was used.During plastic surgery, the moment the primary container of the suture is opened, the surgeon notices that the needle is detached from the thread, so he requests to change it for one in good condition.There were no problems in the patient and the time of surgery was lengthened.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: (b)(6) 2024.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, or its employees that the report constitutes an admission that the product, ethicon, 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One winding former and one detached needle outside its packaging that belong to product code vcp317h.During visual inspection of the detached needle, the swage and attachment area were noted as expected.The barrel hole was examined, and the remnant of the suture was observed.Besides that, the suture cannot be dispensed since has begun with the degradation process.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed due to handling.Per the sample condition, the functional test cannot be performed.As part of the 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: VCL+ VIO 27IN 2-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20358066
• Report Number: 2210968-2024-10499
• Device Sequence Number: 20864816
• Product Code: GAM
• UDI-Device Identifier: 10705031052253
• UDI-Public: (01)10705031052253(17)280820(10)AU9058
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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 Catalogue Number: VCP317H
• Device Lot Number: AU9058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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