MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 1 S/A CT-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8425H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture is cut during surgery.The surgeon uses it in the same way.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.H6 component code: g07002 device not returned a manufacturing record evaluation was performed for the finished device lot number, and no related 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.The following information was requested, but unavailable: - please provide additional details of the reported alleged deficiency.- when did the alleged deficiency happened (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? if other, please explain.- were there patient consequences? if yes, please explain.- how many devices demonstrated the alleged deficiency? -is this device or samples available for product analysis? - is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? - please confirm the quantity of devices available for product analysis --- unfortunately the client has not cooperated so far so we have not been able to provide any additional information or collect the material.

• Brand Name: PRLNE BLU 30IN 1 S/A CT-1
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21773348
• Report Number: 2210968-2025-03563
• Device Sequence Number: 8220447
• Product Code: GAW
• UDI-Device Identifier: 10705031015470
• UDI-Public: (01)10705031015470(17)280930(10)AU9768
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: 8425H
• Device Lot Number: AU9768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2023
• 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