MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 0 S/A V-7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	6965H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a gyn procedure on (b)(6) 2025 and suture was used.During the procedure, 3 ethibond sutures were used.The 1st one: the suture came loose from the needle, the 2nd one: needle broke, the 3rd one: the suture broke.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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.The 1st one: the suture came loose from the needle when was the suture came loose from the needle (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.What was the appearance of the suture/needle during the removal? the 2nd one: needle broke: when was the needle broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.Was the needle piece(s) retrieved during the same procedure? what was the appearance of the suture/needle during the removal? were x-rays taken to locate the needle piece(s)? what measures were implemented to retrieve the broken piece? was there any additional tissue damage resulting from the search for the needle piece? the 3rd one: the suture broke: when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify what was the appearance of the suture during the removal? 3 devices: were there any unexpected outcomes or complications resulting from the prolonged surgery time? which tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? was there any change in the patient¿s post operative care due to the prolonged procedure? could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.Please provide the source or name of person providing answers to follow-up questions: "d4: device is not distributed in the united states, but is similar to device marketed in the usa.Therefore, (01)gtin is not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d9.Device available for evaluation? h3.Device evaluated by manufacturer? additional informaiton: d4.Primary udi number, d9.Date device returned to manufacturer , d9.Is device returned to manufacturer? , h6.Component code, h6.Type of investigation, h6.Investigation findings, h6.Investigation conclusions.H6 component code: g07002 - no device problem found.H3.Investigation summary: the product was returned to ethicon for evaluation.Sixty-seven unopened samples that pertains to product code 6965h were received for analysis.The complaint sample was not returned.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened.The swage and attachment area were noted as expected.The tip and body of the needles were examined under magnification and no anomalies or issues related to needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.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 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 30IN 0 S/A V-7
• 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: 21942345
• Report Number: 2210968-2025-04780
• Device Sequence Number: 21041720
• Product Code: GAT
• UDI-Device Identifier: 10705031090361
• UDI-Public: (01)10705031090361(17)291130(10)105EGE
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/05/2025

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: 6965H
• Device Lot Number: 105EGE
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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