MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 3-0 S/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X832H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an urology procedure (b)(6) 2025 and suture was used.During the procedure, i am writing this email to give some feedback shared by our urology surgeons regarding the ethibond 3-0.We have done penile plication procedures recently, and for the past two occasions, the 3-0 ethibond rb-1 has been breaking when they are tying a knot.While a 3-0 ethibond is quite a small suture, the surgeons believe it should not be breakable by their hands when tying a knot.We opened two sutures today, the 3-0 ethibond on rb1 ref no: (b)(4), lot: sjbdsz, and 3-0 ethibond sh ref no.(b)(4), lot: tlbeqr, and we were able to break it with medium effort.No adverse patient consequences were reported.Additional information was requested.
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.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.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.Additional information was requested, and the following was obtained via: - have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).None known.- how many devices demonstrated the alleged deficiency in each case? please specify by product code and lot number: unknown.- were there patient consequences? if yes, please explain.No.As of today, samples have been recovered for testing from manukau surgical centre.¿ product code x872h- lot sjbdsz: (b)(4).¿ product code x832h- lot tlbeqr: (b)(4).Additional information: was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, (b)(6).Device property of: none, device in possession of: none, (b)(6).Device property of: none, device in possession of: none.
Additional Manufacturer Narrative
Product complaint #: (b)(4).H6 component code: g07002 - no device problem found.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Additional information: h6, d9, h3.H3 investigation summary: the product was returned to ethicon for evaluation.One open box with twenty-two representative unopened samples were received for analysis.Product code x832h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.Following the sampling plan, a visual inspection was conducted on thirteen samples.The packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to the customer complaint and no defects were observed during evaluation.A functional test was performed using instron equipment and tensile force 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.H3 investigation summary: the product was returned to ethicon for evaluation.One open box with seven representative unopened samples was received for analysis.Product code x872h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to the customer complaint and no defects were observed during evaluation.The functional test was performed using instron equipment and the tensile force 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: EB EXC GRN 30IN 3-0 S/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22555692
• Report Number: 2210968-2025-08416
• Device Sequence Number: 9700175
• Product Code: GAT
• UDI-Device Identifier: 10705031058187
• UDI-Public: (01)10705031058187(17)280930(10)TLBEQR
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K946173
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: X832H
• Device Lot Number: TLBEQR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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