MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP493H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.It was reported that the problem of pulling off suture needle happened in surgery.Total 8 products occurred needle pull off issue.Changed another one to complete the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 12/2/2025.H6 component code: g07002 - no device problem found.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 manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested; the following was obtained: when were the needles detached/pulled off from the sutures (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.Received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.H3 investigational summary: the product was returned to eth for evaluation.Visual inspection revelated that twenty-one unopened foil packets were received for analysis.Product code vcp493h.Following the sampling plan, a visual inspection was conducted on 13 samples.No external damage was observed in the packets.The packets were open, and the swage and attachment area were noted to be as expected.The sutures were dispensed without issues.Although, the sutures in all the samples were noted with significant difference in suture¿s diameter and coloration at the tipping area.As per this condition observed in the sutures, the flex test was performed in the twenty-one samples.All sutures broke due to improper tipping, as the sutures were breaking away from the swage area.Based on the information currently available, damaged suture was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Additional h3 investigational summary: the product was returned to eth for evaluation.Visual inspection revelated that one labeled winding former with one needle outside the foil packet was received for analysis.Product code vcp493.The returned needle was visually inspected, and the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined under magnification, and suture remnant was observed.Additionally, the suture was not returned for evaluation, therefore no functional testing could be performed.A manufacturing record evaluation for the finished device batch number revealed no non-conformance's.Per the conditions of the returned sample, no conclusion could be reached regarding the cause of the reported complaint, and there was no information indicating patient involvement or adverse outcomes.As part of eth 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+ UD 18IN 5-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23697159
• Report Number: 2210968-2025-13482
• Device Sequence Number: 21404623
• Product Code: GAM
• UDI-Device Identifier: 10705031053663
• UDI-Public: (01)10705031053663(17)290930(10)103Z90
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: VCP493H
• Device Lot Number: 103Z90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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