MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 5-0 D/A BB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8580H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).H6 component code: g07002: device evaluation pending.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: please provide additional details about the alleged deficiency.The needles got loosened when passing through the prostheses.How long was the delay? please specify in minutes.20 minutes.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? i don't believe, not at the time of surgery, postoperatively.Was there any change in the patient¿s post-operative care due to the prolonged procedure? unknown.Were there patient consequences? if yes, please explain.Not at the time of surgery, postoperatively.How many devices demonstrated the alleged deficiency? 4 threads of the same lot number.It was reported that the event date is june 27, 2025, and the alert date is july 21, 2025.Could you please provide a justification for this variance in the timing of the report related to this files? we wrote the statement on the same day of the event i don't know why there was an alert until 1 months later.Please provide the date of event.27 june.Both incidents took place during the same procedure (1 patient concerned).
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2025 and suture was used.During the procedure, at the time of suture between the valve prosthesis and cardiac prosthesis.The suture between the cardiorotic prosthesis and the aorta the 4 wires used have loosened risk of tearing during suture delay.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 9/18/2025.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.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.Ten representative unopened samples were received for analysis.Product code 8580h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested, the following was obtained: there were no post-operative consequences for the patient.

• Brand Name: PRLNE BLU 36IN 5-0 D/A BB
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22814497
• Report Number: 2210968-2025-09373
• Device Sequence Number: 15706722
• Product Code: GAW
• UDI-Device Identifier: 10705031017337
• UDI-Public: (01)10705031017337(17)47238(10)1011RL
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 8580H
• Device Lot Number: 1011RL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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