MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 4X30IN 5 S/A V-37; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	MB66G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
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.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.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.- please provide additional details about the alleged deficiency.- what does "the suture core separated from the carriers" mean? please provide additional details about this statement.- when did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? if other, please explain.- please confirm, how many devices demonstrated the alleged deficiency? - were there any unexpected outcomes or complications as a result of the prolonged surgery time? - please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.During the procedure, the suture core separated from the carriers, compromising the suture integrity.This occurred during surgery; three sutures were used and had the same issue.The surgery was delayed by 5-7 mins.The surgeon managed to close the tissue layer successfully, no patient impact.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional information was requested, and the following was obtained via: please provide additional details about the alleged deficiency.- what does "the suture core separated from the carriers" mean? please provide additional details about this statement.The ethibond suture strand consists of 16 compact carriers braided around a composite core (see data on file, johnson & johnson ethicon products).The inside (core) of the suture strand pulled out, with the outside carriers crumpled up, like wool where the inside pulls off and is being separated from an inside core.While the surgeon was suturing, the outside stayed behind on one side of the tissue instead of the strand pulling through like a unit - when did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? if other, please explain.While suturing, during passage through tissue.- please confirm, how many devices demonstrated the alleged deficiency? three.- were there any unexpected outcomes or complications as a result of the prolonged surgery time? no.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).(b)(6).
Additional Manufacturer Narrative
Product complaint #(b)(4).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.Additional information received: (b)(4) returned through fed ex tracking number (b)(6).
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information d4.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, 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 Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 9.Device available for evaluation?, h 3.Device evaluated by manufacturer? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 6.Health effect - impact code, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions h3 investigation summary = > the product was returned to ethicon for evaluation.Two empty folders, four unused needle suture combinations and one open box with eleven unopened samples were received for analysis.The product code mb66 is multi-strand and should contain four strands single armed per packet.During the visual inspection of the four needle suture combinations, the swage and attachment area were noted to be as expected.The sutures were examined, and no anomalies or damage were observed during the evaluation.In order to evaluate the condition of eleven unopened samples, the packets were opened.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no anomalies were observed.A functional test was performed using instron equipment and the pull force results were above the minimum requirements.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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, 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.

• Brand Name: EB EXC GRN 4X30IN 5 S/A V-37
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 22686855
• Report Number: 2210968-2025-08930
• Device Sequence Number: 9472767
• Product Code: GAT
• UDI-Device Identifier: 10705031046290
• UDI-Public: (01)10705031046290(17)291031(10)104J2R
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/26/2025

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: MB66G
• Device Lot Number: 104J2R
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 10/07/2025; 11/03/2025; 11/03/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/18/2025; 10/24/2025; 11/26/2025; 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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