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

Catalog Number	8703H
Medical Device Problem Code	Break (1069)
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, part 4 subpart b.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.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.Additional information was requested, and the following was obtained via: what is the current status of the patients? the procedures were completed using other products, no further complications.-the attached photo (b)(4) photo) shows a non¿j&j product.Could you please clarify? i didn't send any photos, the item number on the boxes is 8703h, with the corresponding lot number 10bt7t.Where this picture came from, i cannot provide insight.- was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.Re-suturing/reclosure was completed with different products, details weren't provided.- 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.I have not received return instructions or an rga for the affected product.Please provide that information so that we can return the (b)(4) boxes of product due to continual issues.- please provide the source or name of person providing answers to follow-up questions: ch (please refer to the attached email).There are (b)(4) boxes of product name: prlne blu 30in 7-0 d/a bv-1 product code: 8703h lot number: 10bt7t that are available for return and investigation.A return kit or return shipping label and rga paperwork can be sent directly to me at (please refer to the attached email) and i will pack up and return the samples requested.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2026 and suture was used.During the procedure, it was reported by distributor per account that multiple sutures broke while doing anastomosis on the heart or carotid tissue.They would break anywhere from three throws in to halfway around the anastomosis.Customer reports that this happened to 3 of their 4 surgeons in at least 5 cases, before sutures were pulled from the shelf.They became aware of the issue 2/5 & again on 2/7 pulling all the boxes on 2/9.There is no patient or end-user injury reported.Devices are available for return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PROLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 24698632
• Report Number: 2210968-2026-03108
• Device Sequence Number: 13289351
• Product Code: GAW
• UDI-Device Identifier: 10705031019348
• UDI-Public: (01)10705031019348(17)300930(10)10BT7T
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 8703H
• Device Lot Number: 10BT7T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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