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

Catalog Number	VCP500G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, we have been advised by our supplier (b)(4) to contact johnson and johnson directly regarding a faulty box of sutures purchase.The sutures are ethicon vicryl 5/0 ps-3/8 16mm reverse cutting, 45cm.The issue: the thread keeps detaching from the needle every time we use it.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.Additional information was requested, and the following was obtained via: the investigating team were expecting 2 vcp500g; lot# 103mbh but received (6) vcp500g; lot# 103mbh and (29) lot# 102dbt.Can you please confirm if the lot# 102dbt also belongs to this complaint? response: yes we returned 1 box of lot 103mbh and 3 boxes of lot 102dbt they are all from the one complaint.Please see source data.Dear sir/madam, following up on the email sent by my practice manager, i am dr.(b)(6), principal periodontist at perio perth.I have been using ethicon vicryl sutures for over 13 years and have always found them reliable and easy to handle.Recently, we ordered four boxes of vicryl sutures¿three from (b)(4) and one from (b)(4).After experiencing significant delivery delays, which were already frustrating, we finally received our order.However, upon using these sutures in four separate surgeries, i have noticed a drastic decline in quality that has seriously impacted my clinical procedures.The issues i have encountered include: needles detaching from the threads repeatedly.Sutures exhibiting excessive coiling, even when wet.Increased difficulty in tying knots, with knots frequently coming loose.Rougher texture of the suture material compared to previous batches.These problems were consistent across all four boxes, not limited to a single batch.This significant drop in quality has compromised surgical efficiency, prolonged procedures, and created frustration for both myself and my dental assistant.More critically, it poses a potential risk to patient outcomes, particularly in procedures like gingival grafting and dental implants (the four surgeries that i have done using those sutures), where secure sutures are essential.Given the severity of this issue, i request the following: 1.An immediate investigation into why the quality of these sutures has deteriorated.2.A full refund for the four defective boxes.If this matter is not addressed promptly and satisfactorily, i will have no choice but to escalate my concerns by formally reporting this to the therapeutic goods administration (tga) and the australian competition and consumer commission (accc).Furthermore, if i believe that patient outcomes have been compromised due to the poor quality of these sutures, i will also be submitting a report to the australian health practitioner regulation agency (ahpra).I have attached the invoices for the four boxes we purchased for your reference.I expect a swift response and resolution to this matter.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).H6 component code: g07002 - device evaluation pending 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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Corrected data: d4, d9, h6, h11 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/11/2025.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.Additional information: d4, h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Two open boxes with twelve representative unopened samples and one open box with seven representative unopened samples were received for analysis.Product code vcp500g.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were evident on the exterior packaging.Following the sampling plan, a visual inspection was conducted on thirteen samples.The packets were opened, and swage and attachment areas appeared as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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 PS-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: 22206492
• Report Number: 2210968-2025-06901
• Device Sequence Number: 15175477
• Product Code: GAM
• UDI-Device Identifier: 10705031245143
• UDI-Public: (01)10705031245143(17)290630(10)102DBT
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

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: VCP500G
• Device Lot Number: 102DBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 06/16/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/16/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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