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

Catalog Number	8726H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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: - do you have any photos available for visual analysis? i do not any photos - was the wound re-suturing performed during the initial procedure? if not, please explain when it was performed.- how long was the delay? please specify in minutes.It delayed the surgery, the surgeon had to redo one of his anastomosis because of the suture breaking, but that it did not cause any adverse harm.- were there any unexpected outcomes or complications as a result of the prolonged surgery time? please specify in minutes.It delayed the surgery, the surgeon had to redo one of his anastomosis because of the suture breaking, but that it did not cause any adverse harm.I believe when this happen the vendor (b)(6)was in house and i handed the sutures to her a manufacturing record evaluation was performed for the finished device lot number 10b31e, 8726h-56 and no non-conformances related to the reported complaint condition 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.
Event or Problem Description
It was reported that a patient underwent an anastomosis procedure on an unknown date and suture was used.Several 6-0 sutures kept breaking during anastomosis with no cause.Scrub nurse/surgeon suspect that sutures were faulty as it would break very easily.Sutures were not expired however noticed all the faulty sutures (3 suture packs) were from same.Removed these sutures from operating room pyxis.New packs opened and used with different lot number.No issues noted with these.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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25697723
• Report Number: 2210968-2026-07004
• Device Sequence Number: 9720323
• Product Code: GAW
• UDI-Device Identifier: 10705031019805
• UDI-Public: (01)10705031019805(17)300831(10)10B31E
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: 8726H
• Device Lot Number: 10B31E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2025
• 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