MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J260H
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 a total vaginal hysterectomy on an unknown date and suture was used.During the procedure, upon vaginal cuff closure, the suture broke away from the needle.When applying tension after the surgeon takes a bite, when they grasp the suture is popping off.There were no adverse patient consequences 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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.H3 investigation summary: the product was returned to ethicon for evaluation.One paper lid, a detached needle and one used suture piece were received for analysis.Product code j260h.After investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.Based on the information currently available, short insertion issue was identified as pull out 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.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts were made to obtain the information.If further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: - please confirm the number of patients affected by this alleged deficiency (".Over the course of several weeks during total vaginal hysterectomy's, specially during the vaginal cuff closure.While using a vicryl suture the suture broke away from the needle.")? - i do not have the number of patients at this time.- have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).- they have not, this is the first reported event.Please provide information requested below for each patient/event.- were there patient consequences? if yes, please explain.- no patient consequences to report - can you identify the lot numbers of product codes vcp215h and vcp417h? - i am not able to identify the lot numbers from the suture that he reported to me had broken away from the needle.- please confirm below, how many devices demonstrated the alleged deficiency? j260h - lot number 1046xj: - unknown vcp215h - lot number unknown: - unknown vcp417h- lot number unknown: - unknown - please confirm if the devices are available for product return.If yes, confirm the quantity of devices available for product analysis and provide the status of the devices as they have not been received for analysis.If the device has been shipped, please provide the shipment tracking details.- product has been shipped and confirmed to have been received.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).- dr.(please refer the attached email- re: 2nd product complaint follow-up pc-(b)(4).- please provide additional details of the reported alleged deficiency ("¿two needles, codes unknown are also available that were retained.").- please confirm, did the needles fall into the patient(s)? if not, please explain.No they did not.If yes, please provide the following information: - were there patient consequences? if yes, please explain.- were x-rays taken to locate the needles? - were the needles removed from the patient(s) during the same procedure? - was there any additional tissue damage as a result of searching for the needles? *if not retrieved, in what tissue structure the needle piece(s) were retained? is there any plan in place to remove the needle(s) in the future? please provide details.- if available, please provide the product codes and lot numbers.Just wanted to confirm that these are just additional users (as the team was wanting to understand if other surgeons were having pull off issues) and there hasn¿t been any new complaints that need to be created for these codes or these surgeons? - these are just additional users of these sutures.We discussed on our call finding out if there were other surgeons in the hospital using these exact codes.The or manager provided me a list of names that may be helpful with discussion with dr.V as there has been no complaints of suture detaching from needles from those individuals listed.In addition, is vcp311h a new complaint from dr.V or a new complaint from another surgeon? - vcp311h should have been made part of the initial complaint.I did call this code in today and they are generating a new complaint number for this but noting that it was sent in with the additional boxes sent to me for (b)(4) this box has already been shipped from stl the product vcp311h was not in the original product complaint, but i was sent to you with the action of the (b)(4).It has been returned already.

• Brand Name: VCL CT BRD UD 27IN 0 S/A CT-1
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21632646
• Report Number: 2210968-2025-02815
• Device Sequence Number: 12649179
• Product Code: GAM
• UDI-Device Identifier: 10705031038332
• UDI-Public: (01)10705031038332(17)290930(10)1046XJ
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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: J260H
• Device Lot Number: 1046XJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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