MAUDE Adverse Event Report: Ethicon Inc. PROLENE; Suture, Nonabsorbable, Synthetic

Catalog Number	EPM8702
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
Event or Problem Description
It was reported a patient underwent a cabg procedure on an unknown date in 2026 and suture was used.Surgeon had a needle from suture pop off the suture when she was throwing down knots.The needle was found, the case was completed as normal and there was no patient consequence.There was no patient consequence reported.An additional 20 minutes was added to the case.The device was not returning.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint #(b)(4) additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.When was the needle detached/pulled off from the suture(s) (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify- the needle detached from the suture during use on the patient after the suturing was complete and before the surgeon tied down the suture were there any unexpected outcomes or complications resulting from the prolonged surgery time? the needle detaching from the suture was the unexpected outcome which tissue was being sutured when the event occurred? unknown was additional dissection required in other organs/tissues other than the target tissue? no was there any change in the patient¿s post operative care due to the prolonged procedure? no how many devices demonstrated the alleged deficiency? it was reported by the surgeon that the needle detaching from the suture has happened on several cases but the exact number is unknown did the event occur during one or multiple patient procedures? this event has occurred with multiple patients what is the total number of procedures? unknown have any of these events been previously reported to ethicon? no, this event was the first time the rep was made aware 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)? the surgeon is unaware as to how many times this event has occurred please provide the source or name of person providing answers to follow-up questions: (b)(6)/ssl-kaiser-jjmts.The single complaint was reported with multiple events.There are no additional details regarding the additional events.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.No product is available for return.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: 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 ; +1(303)552-6892
• MDR Report Key: 50886682
• Report Number: 2210968-2026-09610
• Device Sequence Number: 15937643
• Product Code: GAW
• UDI-Device Identifier: 10705031134805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: EPM8702
• Device Lot Number: 10CTDE
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2026
• 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