MAUDE Adverse Event Report: ETHICON INC. PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8746
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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, 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.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.How many devices demonstrated the alleged deficiency? did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? if this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? did the reported issue contribute to any patient adverse consequences? when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify 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: the following information was received: what is the product family/product code associated with this reported issue(s)? epm8746- 7-0 prolene suture with everpoint cardiovascular needle.Please provide an overview of the situation to include the actions you have taken locally to address? i have spoken with multipe cv team leads that have informed me of the needle continuing to pop off of these sutures.I have identified the suture code & lot # associated with this problem.Have you been in surgery with this customer since this report to better understand this issue? n.Surgeon experience with the device? 5 plus years.How has local/regional commercial leadership been involved to help resolve this issue to date? (regional sales specialist, sales manager, etc.) none as of yet, (b)(6) (please refer to the rrt form) is out of town as of now.Are surgical procedure or device photographs/videos available for review by the rrt? (if so, please provide electronically).No photos as of right now, but i do have opened box that will be sent back.What is the desired outcome of the rapid response team involvement? (b)(6) team would like to send back the 8 boxes of this lot # 10c1sg and would like a different lot # to be sent to them.Additional information? if possible, my customer is requesting a different lot # other than ¿10c1sg¿ to be sent to them.
Event or Problem Description
It was reported that a patient underwent a cabg procedure in 2026 and suture was used.During the procedure, it was reported by the customer to the sales rep that during a cabg procedure, the needles are popping off.No additional information provided.Devices are returning.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PROLENE
• Common Device Name: SUTURE, NONABSORBABLE, 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: 25231472
• Report Number: 2210968-2026-05601
• Device Sequence Number: 10238450
• Product Code: GAW
• UDI-Device Identifier: 10705031203686
• UDI-Public: (01)10705031203686(17)301031(10)10C1SG
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2026

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: EPM8746
• Device Lot Number: 10C1SG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 06/16/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/05/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown