MAUDE Adverse Event Report: ETHICON INC. PRLNE HS BLU 36IN 5-0 D/A C-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPH8720H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
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, 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-conformances were identified.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 via: did the event occur during one or multiple patient procedures? unk.What is the total number of procedures? unk.Have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? (b)(4).Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).(b)(6).Suture breakage during suturing is a common occurrence.The doctor said that prolene suture breakage during suturing is a common occurrence regardless of its thickness.In the past, there have been complaint reports related to suture breakage for different product codes, so we have listed them below for your reference.(b)(4).
Event or Problem Description
It was reported that a patient underwent a coronary procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported by a sales rep that, during coronary button anastomosis in a bentall procedure, the suture broke when it was pulled after putting about three stitches.Suture breakage during suturing is a common occurrence.Additional suture was performed to complete the case.No sample will be returned.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE HS BLU 36IN 5-0 D/A C-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 24130382
• Report Number: 2210968-2026-00750
• Device Sequence Number: 10344652
• Product Code: GAW
• UDI-Device Identifier: 10705031233447
• UDI-Public: (01)10705031233447(17)290831(10)103H93
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/21/2026

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: EPH8720H
• Device Lot Number: 103H93
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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