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

Catalog Number	8412H
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.It was reported visible suture fraying and thinning after multiple passes.There were no patient consequences reported.There were no surgical delays reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 4/17/2026.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested, the following was obtained: were there any patient consequences? no.What is the procedure name? inguinal hernia shouldice tension repair.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).Surgeon: dr.(b)(6).Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Device returned march 25th.The following information was received: additional notes based on surgeon discussion: the shouldice method is a four-layer, tension-based hernia repair technique.Historically, the group has used steel sutures and transitioned to polypropylene sutures approximately three months ago.Suturing technique: the suture is run from the pubic tubercle laterally toward the anterior superior iliac spine (asis) (layer 1) and back, (layer 2) then tied off.The surgeon then performs a second run from the pubic tubercle toward the asis, completing layers 3 and 4.Suture fraying/splitting was observed toward the end of layer three or four.This occurred on the upper half of the suture towards the swage he guessed around 3 inches distal to the swage.He noted no graspers or instruments were applied in this area.Minimal handling of the suture was reported at the site where fraying was observed.H3: investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one paper lid, one empty winding former and one needle suture piece in two sections were received for analysis.Product code 8412.Upon inspection of the returned sample revealed a split suture with end that appeared cut, likely by a surgical instrument.Body fluids were present on the needle, and the strand showed signs of crushing.Per the conditions of the returned sample the functional test could not be performed.As part of eth quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• 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: 24910434
• Report Number: 2210968-2026-04110
• Device Sequence Number: 13243984
• Product Code: GAW
• UDI-Device Identifier: 10705031015265
• UDI-Public: (01)10705031015265(17)300531(10)1094GA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 8412H
• Device Lot Number: 1094GA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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