MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 3-0 S/A KS; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8622H
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
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.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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.H6 component code: g07002 device not returned.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: there were no complications with the patient.The product was delivered today at j&j's facility.Procedure: reduction mammoplasty.
Event or Problem Description
It was reported that a patient underwent a mammoplasty on (b)(6) 2025 and suture was used.During the procedure, the suture frayed and when knotted breaks.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional information: h6.The following information was received: the sample arrived to the cq location and will be shipped to cg labs.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/16/2025 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.Additional information: d9, h3, h6 h3 investigational summary: the product was returned to ethicon for evaluation.One needle suture combination it two sections and one empty winding former inside the petri dish were received for analysis.During the visual inspection of the returned sample, the swage and attachment area were noted to be as expected.The suture pieces were examined, and the ends were observed split and elongated.Besides that, crimping marks were noted on the sutures.Per conditions of the returned sample, the functional test could not be performed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the 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: PRLNE BLU 30IN 3-0 S/A KS
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21606416
• Report Number: 2210968-2025-02702
• Device Sequence Number: 21151183
• Product Code: GAW
• UDI-Device Identifier: 10705031017931
• UDI-Public: (01)10705031017931(17)270630(10)AT3088
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2025

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: 8622H
• Device Lot Number: AT3088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 05/20/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/05/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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